Allergenic Extract, Vegetable

Dosage Form: injection, solution

Allergenic Extract

Warnings

Allergenic extract is intended for use by, or under the guidance of, physicians who are experienced in the administration of allergenic extracts for diagnosis and/or immunotherapy and the emergency care of anaphylaxis. This extract is not directly interchangeable with other allergenic extracts. The initial dose must be based on skin testing as described in the “DOSAGE AND ADMINISTRATION” section of this insert. Patients switching from other types of extracts to Antigen Laboratories’ allergenic extracts should be started as if they were undergoing treatment for the first time. Patients being switched from one lot of extract to another from the same manufacturer should have the dose reduced by 75%.

Severe systemic reactions may occur with all allergenic extracts. In certain individuals, especially in steroid-dependent/unstable asthmatics, these life-threatening reactions may result in death. Patients should be observed for at least 20 minutes following allergenic extract injections. Treatment and emergency measures, as well as personnel trained in their use, must be available in the event of a life-threatening reaction. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death. Report serious adverse events to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, phone 1-800-FDA-1088.

This product should not be injected intravenously. Deep subcutaneous routes have proven to be safe. See the “WARNINGS”, “PRECAUTIONS”, “ADVERSE REACTIONS” and “OVERDOSAGE” sections.

Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require theophylline, oxygen, intubation and the use of life support systems. Parenteral fluid and/or plasma expanders may be utilized for treatment of shock. Adrenocorticosteroids may be administered parenterally or intravenously. Refer to “WARNINGS”, “PRECAUTIONS” and “ADVERSE REACTIONS” sections below.

Allergenic Extract, Vegetable Description

Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin.

FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:

INACTIVE INGREDIENTS:

Sodium chloride…………………………………………………………….0.95%

Sodium bicarbonate………………………………………………………..0.24%

Glycerine…………………………………………………………………50% (v/v)

Water for Injection…………………………………………………q.s. to volume

Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular.

Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v).

Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.

Allergenic Extract, Vegetable - Clinical Pharmacology

Studies indicate allergic individuals produce immunoglobulins of the IgE class in response to exposure to allergens. Subsequent exposure to the allergen results in a combination of allergen with IgE antibody fixed on mast cells or basophil membranes. This cross-linking results in stimulation of mast cell which leads to release and generation of pharmacologically active substances that produce immediate hypersensitivity reaction.3

The mode of action of immunotherapy with allergenic extracts is still under investigation. Subcutaneous injections of increasing doses of allergenic extract into patients with allergic disease have been shown to result in both humoral and cellular changes including the production of allergen-specific IgG antibodies, the suppression of histamine release from target cells, decrease in circulating levels of antigen specific IgE antibody over long periods of time and suppression of peripheral blood T-lymphocyte cell responses to antigen.10, 14, 15

Indications and Usage for Allergenic Extract, Vegetable

Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.

Contraindications

Do not administer in the presence of diseases characterized by bleeding diathesis. Individuals with autoimmune disease may be at risk of exacerbating symptoms of the underlying disease, possibly due to routine immunization. Patients who have experienced a recent myocardial infarction may not be tolerant of immunotherapy. Children with nephrotic syndrome probably should not receive injections due to immunization causing exacerbation of nephrotic disease.

Warnings

Refer to boxed “WARNINGS”, “PRECAUTIONS”, “ADVERSE REACTIONS” and “OVERDOSAGE” sections for additional information on serious adverse reactions and steps to be taken, if any occur.

Extreme caution is necessary when using diagnostic skin tests or injection treatment in highly sensitive patients who have experienced severe symptoms or anaphylaxis by natural exposure, or during previous skin testing or treatment. IN THESE CASES THE POTENCY FOR SKIN TESTS AND THE ESCALATION OF THE TREATMENT DOSE MUST BE ADJUSTED TO THE PATIENT’S SENSITIVITY AND TOLERANCE.

Benefit versus risk needs to be evaluated in steroid dependent asthmatics, patients with unstable asthma or patients with underlying cardiovascular disease.

Injections should never be given intravenously. A 5/8 inch, 25 gauge needle on a sterile syringe allows deep subcutaneous injection. Withdraw plunger slightly after inserting needle to determine if a blood vessel has been entered.

Proper measurement of dose and caution in making injection will minimize reactions. Adverse reactions to allergenic extracts are usually apparent within 20-30 minutes following injection of immunotherapy.

Extract should be temporarily withheld or dosage reduced in case of any of the following conditions: 1) flu or other infection with fever; 2) exposure to excessive amounts of allergen prior to injection; 3) rhinitis and/or asthma exhibiting severe symptoms; 4) adverse reaction to previous injection until cause of reaction has been evaluated by physician supervising patient’s immunotherapy program.

Precautions

General:

Immunotherapy must be given under physician’s supervision. Sterile solutions, vials, syringes, etc. must be used. Aseptic technique must be observed in making dilutions from stock concentrates. The usual precautions in administering allergenic extracts are necessary, refer to boxed WARNINGS and “WARNINGS” section. Sterile syringe and needle must be used for each individual patient to prevent transmission of serum hepatitis, Human Immunodeficiency Virus (HIV) and other infectious agents.

Epinephrine 1:1000 should be available. Refer to “OVERDOSAGE” section for description of treatment for anaphylactic reactions.

Information for Patients:

Patient should remain under observation of a nurse, physician, or personnel trained in emergency measures for at least 20 minutes following immunotherapy injection. Patient must be instructed to report any adverse reactions that occur within 24 hours after injection. Possible adverse reactions include unusual swelling and/or tenderness at injection site, rhinorrhea, sneezing, coughing, wheezing, shortness of breath, nausea, dizziness, or faintness. Immediate medical attention must be sought for reactions that occur during or after leaving physician’s office.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Long term studies in animals have not been conducted with allergenic extract to determine their potential for carcinogenicity, mutagenicity or impairment of fertility.

Pregnancy Category C:

Animal reproduction studies have not been conducted with allergenic extracts. It is not known whether allergenic extracts cause fetal harm during pregnancy or affect reproductive capacity. A systemic reaction to allergenic extract could cause uterine contractions leading to spontaneous abortion or premature labor. Allergenic extracts should be used during pregnancy only if potential benefit justifies potential risk to fetus.11

Nursing Mothers:

It is not known whether allergenic extracts are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when allergenic extracts are administered to a nursing woman.

Pediatric Use:

Allergenic extracts have been used routinely in children, and no special safety problems or specific hazards have been found. Children can receive the same dose as adults. Discomfort is minimized by dividing the dose in half and administering injection at two different sites.16, 17

Drug Interactions:

Antihistamines. Antihistamines inhibit the wheal and flare reaction. The inhibitory effect of conventional antihistamines varies from 1 day up to 10 days, according to the drug and patient’s sensitivity. Long acting antihistamines (e.g., astemizole) may inhibit the wheal and flare for up to forty days.1, 2

Imipramines, phenothiazines, and tranquilizers. Tricyclic antidepressants exert a potent and sustained decrease of skin reactions to histamine. This effect may last for a few weeks. Tranquilizers and antiemetic agents of the phenothiazine class have H1 antihistaminic activity and can block skin tests.1

Corticosteroids. Short-term (less than 1 week) administration of corticosteroids at the therapeutic doses used in asthmatic patients does not modify the cutaneous reactivity to histamine, compound 48/80, or allergen. Long-term corticosteroid therapy modifies the skin texture and makes the interpretation of immediate skin tests more difficult.1

Theophylline. It appears that theophylline need not be stopped prior to skin testing.1

Beta-Blockers. Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. The following are commonly prescribed beta-blockers: Levatol, Lopressor, Propanolol Intersol, Propanolol HCL, Blocadren, Propanolol, Inderal-LA, Visken, Corgard, Ipran, Tenormin, Timoptic. Ophthalmic beta-blockers: Betaxolol, Levobunolol, Timolol, Timoptic. Chemicals that are beta-blockers and may be components of other drugs: Acebutolol, Atenolol, Esmolol, Metoprolol, Nadolol, Penbutolol, Pindolol, Propanolol, Timolol, Labetalol, Carteolol.1

Beta-adrenergic agents. Inhaled beta2 agonists in the usual doses used for the treatment of asthma do not usually inhibit allergen-induced skin tests. However, oral terbutaline and parenteral ephedrine were shown to decrease the allergen-induced wheal.1

Cromolyn. Cromolyn inhaled or injected prior to skin tests with allergens or degranulating agents does not alter skin whealing response.1

Other drugs. Other drugs have been shown to decrease skin test reactivity. Among them, dopamine is the best-documented compound.1

Specific Immunotherapy. A decreased skin test reactivity has been observed in patients undergoing specific immunotherapy with pollen extracts, grass pollen allergoids, mites, hymenoptera venoms, or in professional beekeepers who are spontaneously desensitized. Finally, it was shown that specific immunotherapy in patients treated with ragweed pollen extract induced a decreased late-phase reaction.1

Adverse Reactions

Adverse reactions include, but are not limited to urticaria; itching; edema of extremities; respiratory wheezing or asthma; dyspnea; cyanosis; tachycardia; lacrimation; marked perspiration; flushing of face, neck or upper chest; mild persistent clearing of throat; hacking cough or persistent sneezing.

1) Local Reactions

A mild burning immediately after injection is expected; this usually subsides in 10-20 seconds. Prolonged pain or pain radiating up arm is usually the result of intramuscular injection, making this injection route undesirable. Subcutaneous injection is the recommended route.

Small amounts of erythema and swelling at the site of injection are common. Reactions should not be considered significant unless they persist for at least 24 hours or exceed 50 mm in diameter.

Larger local reactions are not only uncomfortable, but indicate the possibility of a severe systemic reaction if dosage is increased. In such cases dosage should be reduced to the last level not causing reaction and maintained for two or three treatments before cautiously increasing.

Large, persistent local reactions or minor exacerbations of the patient’s allergic symptoms may be treated by local cold applications and/or use of oral antihistamines.

2) Systemic Reactions

Systemic reactions range from mild exaggeration of patient’s allergic symptoms to anaphylactic reactions.14 Very sensitive patients may show a rapid response. It cannot be overemphasized that, under certain unpredictable combinations of circumstances, anaphylactic shock is always a possibility. Fatalities are rare but can occur.5 Other possible systemic reaction symptoms are fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis,and urticaria.13, 14

Careful attention to dosage and administration limit such reactions. Allergenic extracts are highly potent to sensitive individuals and OVERDOSE could result in anaphylactic symptoms. Therefore, it is imperative that physicians administering allergenic extracts understand and prepare for treatment of severe reactions. Refer to “OVERDOSAGE” section.

Overdosage

Refer to “WARNINGS”, “PRECAUTIONS” and “ADVERSE REACTIONS” sections for signs and symptoms of an overdose.

If a systemic or anaphylactic reaction does occur, apply tourniquet above the site of allergenic extract injection and inject intramuscularly or subcutaneously 0.3 to 0.5 ml of 1:1000 Epinephrine-hydrochloride into the opposite arm or gluteal area. Repeat dose in 5-10 minutes if necessary. Loosen tourniquet briefly at 5 minute intervals to prevent circulatory impairment. Discontinue use of the tourniquet after ½ hour.

The epinephrine HCL 1:1000 dose for infants to 2 years is 0.05 to 0.1 ml; for children 2 to 6 years it is 0.15 ml; for children 6 to 12 years it is 0.2 ml.

Symptoms of progressive anaphylaxis include airway obstruction and/or vascular collapse. After administration of epinephrine, profound shock and vasomotor collapse should be treated with intravenous fluids and possibly vasoactive drugs. Monitor airways for obstruction. Oxygen should be given by mask if indicated.

Antihistamines, H2 antagonist, bronchodilators, steroids and theophylline may be used as indicated after providing adequate epinephrine and circulatory support.4

Patients who have been taking beta-blockers may be unresponsive to epinephrine. Epinephrine or beta-adrenergic drugs (Alupent) may be ineffective. These drugs should be administered even though a beta-blocker may have been taken. The following treatment will be effective whether or not patient is taking a beta-blocker: Aminophylline IV, slow push or drip, Atrovent (Ipratropium bromide) Inhaler, 3 inhalations repeated, Atropine, 0.4 mg/ml, 0.75 to 1.5 ml IM or IV, Solu-Cortef, 100-200 mg IM or IV, Solu-Medrol, 125 mg IM or IV, Glucagon, 0.5-1 mg IM or IV, Benadryl, 50 mg IM or IV, Cimetidine, 300 mg IM or IV, Oxygen via ambu bag.

Allergenic Extract, Vegetable Dosage and Administration

Refer to “STORAGE” section for proper storage condition for allergenic extract. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Some allergenic extracts naturally precipitate.

Physicians undertaking immunotherapy should be concerned with patient’s degree of sensitivity. The initial dilution of allergenic extract, starting dose, and progression of dosage must be carefully determined on the basis of the patient’s history and results of skin tests. Strongly positive skin tests may be risk factors for systemic reactions. Less aggressive immunotherapy schedules may be indicated for such patients.

Precaution is necessary when using extract mixture for skin testing. The diluting effect of individual components within a mixture may cause false negative reactions. Patients extremely sensitive to a common allergen in several components of a mixture may be more likely to experience a systemic reaction than when skin tested individually for each component.9

PRICK-PUNCTURE TESTING: To identify highly sensitive individuals and as a safety precaution, it is recommended that a prick-puncture test using a drop of the extract concentrate be performed prior to initiating very dilute intradermal testing. Prick-puncture testing is performed by placing a drop of extract concentrate on the skin and puncturing the skin through the drop with a small needle such as a bifurcated vaccinating needle. The most satisfactory sites on the back for skin testing are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins. The best areas on the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anticubital space. A positive reaction is approximately 10-15 mm erythema with 2.5 mm wheal. Smaller, less conclusive reactions may be considered positive in conjunction with a definitive history of symptoms on exposure to the allergen. The more sensitive the patient the higher the probability that he/she will have symptoms related to the exposure of the offending allergen. Hence, the importance of a good patient history. Less sensitive individuals can be tested intradermally with an appropriately diluted extract.

A positive control using histamine phosphate identifies patients whose skin may not react due to medications, metabolic or other reasons. A negative control (50% glycerine for prick-puncture testing) would exclude false-positive reactions due to ingredients in diluent or patients who have dermatographism.

SINGLE DILUTION INTRADERMAL TESTING: The surface of the upper and lower arm is the usual location for skin testing. It is important that a new, sterile, disposable syringe and needle be used for each extract tested. Intracutaneous test dilutions, five-fold or ten-fold, may be prepared from stock concentrate using physiologic saline as a diluent. (1) Start testing with the most dilute allergenic extract concentration. (2) A volume of 0.02-0.05 ml should be injected slowly into the superficial skin layers making a small bleb (superficial wheal). (3) For patients without a history of extreme sensitivity, or a negative or weakly reactive prick-puncture test, the initial dilution for skin testing should be a dilution at least 1:12,500 w/v. This initial dilution can be prepared by diluting 1:20 to 1:50 w/v (2%-5%) extracts five-fold to 5-4 or 1:10 w/v (10%) extracts to 5-5. See “Serial Dilutions Titration Test Dilutions” chart on the next page. Dilute 1:10 w/v (10%) extracts to 10-3 if using ten-fold dilutions. (4) Sensitive patients with a positive prick-puncture test require a further dilution to at least 1:312,500 w/v. This dilution can be prepared by diluting 1:20 to 1:50 w/v (2% - 5%) extracts to 5-6 or 1:10 w/v (10%) extracts to 5-7 (five-fold dilutions). Ten-fold dilution to 10-6 of a 1:10 w/v (10%) extract would be a safe starting dilution. Size of reactions are quantitated based on size of wheal and erythema. For interpretation of skin reactions, refer to chart below. If after 20 minutes no skin reaction is observed, continue testing using increasing increments of the concentration until a reaction of 5-10 mm wheal and 11-30 mm erythema is obtained, or a concentration of 5-2 or 10-1 has been tested. A negative control, 50% glycerine diluted with diluent to 5-2 (1:25) or 10-1 (1:10) dilution and a positive control of histamine phosphate, should be tested and included in interpretation of skin reactions.1, 13

GRADE mm ERYTHEMA mm WHEAL
0 less than 5 less than 5
± 5-10 5-10
1+ 11-20 5-10
2+ 21-30 5-10
3+ 31-40 10-15 or with pseudopods
4+ greater than 40 greater than 15 or with many pseudopods

INTRADERMAL TESTING-SKIN ENDPOINT TITRATION: The allergenic extracts to which the patient is sensitive, the patient’s degree of sensitivity and the dose of allergen to be used in immunotherapy can be determined through the use of intracutaneous skin tests involving progressive five-fold dilutions of allergenic extracts. Intracutaneously inject 0.01 to 0.02 ml of the test allergen to form a 4 mm diameter superficial skin wheal. For patients demonstrating a negative or weakly reactive prick-puncture skin test, an initial screening dilution of 1:12,500 w/v is safe. For patients demonstrating a positive prick-puncture skin test, an initial screening dilution of 1:312,500 w/v is safe. (See “Serial Dilution Titration Test Dilutions” chart below.) When a sequence of five-fold or ten-fold dilutions of an allergen are injected, the endpoint is determined by noting the dilution that first produces a wheal and erythema (15 minutes after injection) that is 2 mm larger than wheals with erythema produced by weaker, non-reacting dilutions (5 mm negative wheal). The endpoint dilution is used as a starting dose concentration for immunotherapy. An endpoint dose of 0.15 ml is a safe initial dose to be followed by escalation to the optimal maximum tolerated dose for each individual.

Injections should never be given intravenously. A 5/8 inch, 25 gauge needle on a sterile syringe will allow deep subcutaneous injection.

IMMUNOTHERAPY: If the first injection of the initial dilution of extract is tolerated without significant local reaction, increasing doses by 5-20% increments of that dilution may be administered. The rate of increase in dosage in the early stages of treatment with highly diluted extracts is usually more rapid than the rate of increase possible with more concentrated extracts. This schedule is intended only as a guide and must be modified according to the reactivity of the individual patient. Needless to say, the physician must proceed cautiously in the treatment of the highly sensitive patient who develops large local or systemic reactions.6

Some patients may tolerate larger doses of the allergenic extract depending on patient response.7 Because diluted extract tends to lose activity in storage, the first dose from a more concentrated vial should be the same, or less than, the previous dose.8, 12

Dosages progressively increase according to the tolerance of the patient at intervals of one to seven days until, (1) the patient achieves relief from symptoms, (2) induration at the site of injection is no larger than 50 mm in 36 to 48 hours, (3) a maintenance dose is reached (the largest dose tolerated by the patient that relieves symptoms without undesirable local or systemic reactions). This maintenance dose may be continued at regular intervals perennially. It may be necessary to adjust the progression of dosage downward to avoid local and constitutional reactions.

The usual duration of treatment has not been established. A period of two or three years on immunotherapy constitutes an average minimum course of treatment.

SERIAL DILUTION TITRATION TEST DILUTIONS APPROXIMATE ALLERGENIC EXTRACT CONCENTRATION RESULTING FROM 1:5 DILUTION
Titration Number Dilution Exponent Weight / Volume Allergenic Extract Concentrate
1:50 2% 1:40 2 1/2% 1:33 1/3 3% 1:20 5% 1:10 10%
No. 1 5-1 1:5 1:250 1:200 1:167 1:100 1:50
No. 2 5-2 1:25 1:1,250 1:1,000 1:835 1:500 1:250
No. 3 5-3 1:125 1:6,250 1:5,000 1:4,175 1:2,500 1:1,250
No. 4 5-4 1:625 1:31,250 1:25,000 1:20,875 1:12,500 1:6,250
No. 5 5-5 1:3,125 1:156,250 1:125,000 1:104,375 1:62,500 1:31,250
No. 6 5-6 1:15,625 1:781,250 1:625,000 1:521,875 1:312,500 1:156,250
No. 7 5-7 1:78,125 1:3,906,250 1:3,125,000 1:2,609,375 1:1,562,500 1:781,250
No. 8 5-8 1:390,625 1:19,531,250 1:15,625,000 1:13,046,875 1:7,812,500 1:3,906,250
No. 9 5-9 1:1,953,125 1:97,656,250 1:78,125,000 1:65,234,375 1:39,062,500 1:19,531,250
No. 10 5-10 1:9,765,625 1:488,281,250 1:390,625,000 1:326,171,875 1:195,312,500 1:97,656,250
No. 11 5-11 1:48,828,125 1:2,441,406,250 1:1,953,125,000 1:1,630,859,375 1:976,562,500 1:488,281,250
No. 12 5-12 1:244,140,625 1:12,207,031,250 1:9,765,625,000 1:8,154,296,875 1:4,882,812,500 1:2,441,406,250

How is Allergenic Extract, Vegetable Supplied

Stock concentrates are available in concentrations of 2-10% or weight/volume (w/v) of 1:50, 1:33, 1:20 or 1:10. Some juicy or liquid foods are available at 1:1 volume/volume (v/v) extraction ratio. Fresh egg white extract is available at 1:9 v/v extraction ratio.

Antigen E content of ragweed mixtures ranges from 46-166 U/ml for Ragweed Mixture (Short/Giant/Western/Southern Ragweed), 47-239 U/ml for Short/Giant/Western Ragweed Mixture, and 106-256 U/ml for Short/Giant Ragweed Mixture. Refer to container label for actual Antigen E content.

Extract (stock concentrate) is supplied in 10, 30 and 50 ml containers. Extracts in 5 ml dropper bottles are available for prick-puncture testing. To insure maximum potency for the entire dating period, all stock concentrates contain 50% glycerine v/v.

STORAGE

Store all stock concentrates and dilutions at 2-8° C. Keep at this temperature during office use. The expiration date of the allergenic extracts is listed on the container label. Dilutions of the allergenic extracts containing less than 50% glycerine are less stable. If loss of potency is suspected, potency can be checked using side by side skin testing with freshly prepared dilutions of equal concentration on individuals with known sensitivity to the allergen.

REFERENCES

1. Bousquet, Jean: “In vivo methods for study of allergy: Skin tests” Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. I, Chap. 19, pp 419-436, 1988.

2. Long, W.F., Taylor, R.J., Wagner, C.J., et al.: Skin test suppression by antihistamines and the development of subsensitivity, J. Allergy Clin. Immunol., pp. 76-113, 1985.

3. Holgate, S.T., Robinson, C., Church, Mike: Mediators of Immediate Hypersensitivity, Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. I and II, pp 135-163, 1988.

4. Wasserman, S., Marquart, D.: Anaphylaxis, Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. 1, Chap. 58, pp. 1365-1376, 1988.

5. Reid, Michael J., Lockey, Richard F., Turkeltaub M.D., Paul C., Platts-Mills, Thomas. “Survey of Fatalities from Skin Testing and Immunotherapy 1985-1989”, Journal of Allergy and Clinical Immunology, Vol. 92, No. 1, pp. 6-15, 1993.

6. Matthews, K., et al: Rhinitis, Asthma and Other Allergic Diseases. NIAID Task Force Report, U.S. Dept. HEW, NIH Publication No. 79-387, Chapter 4, pp. 213-217, May 1979.

7. Ishizaka, K.: Control of IgE Synthesis, Third Edition, Allergy Principles and Practices, Vol. I, Chap. 4, p. 52, edited by Middleton et al.

8. Nelson, H.S.: “The Effect of Preservatives and Dilution on the Deterioration of Russian Thistle (Salsola pestifer), a pollen extract.” The Journal of Allergy and Clinical Immunology, Vol. 63, No. 6, pp. 417-425, June 1979.

9. Seebohm, P.M., et al: Panel on Review of Allergenic Extracts, Final Report, Food and Drug Administration, March 13, 1981, pp. 84-86.

10. Rocklin, R.E., Sheffer, A.L., Grainader, D.K. and Melmon, K.: “Generation of antigen-specific suppressor cells during allergy desensitization”, New England Journal of Medicine, 302, May 29, 1980, pp. 1213-1219.

11. Seebohm, P.M., et al: Panel on Review of Allergenic Extracts, Final Report, Food and Drug Administration, March 13, 1981, pp 9-48.

12. Stevens, E.: Cutaneous Tests, Regulatory Control and Standardization of Allergenic Extracts, First International Paul-Ehrlich Seminar, May 20-22, 1979, Frankfurt, Germany, pp. 133-138.

13. Van Metre, T., Adkinson, N., Amodio, F., Lichtenstein, L., Mardinay, M., Norman, P., Rosenberg, G., Sobotka, A., Valentine, M.: “A Comparative Study of the Effectiveness of the Rinkel Method and the Current Standard Method of Immunology for Ragweed Pollen Hay Fever,“ The Journal of Clinical Allergy and Immunology, Vol. 66, No. 6, p. 511, December 1980.

14. Wasserman, S.: The Mast Cell and the Inflammatory Response. The Mast Cell-its role in Health and disease. Edited by J. Pepys & A.M. Edwards, Proceedings of an International Symposium, Davos, Switzerland, Pitman Medical Publishing Co., 1979, pp. 9-20.

15. Perelmutter, L.: IgE Regulation During Immunotherapy of Allergic Diseases. Annals of Allergy, Vol. 57, August 1986.

16. Bullock, J., Frick, O.: Mite Sensitivity in House Dust Allergic Children, Am. J. Dis. Child., pp. 123-222, 1972.

17. Willoughby, J.W.: Inhalant Allergy Immunotherapy with Standardized and Nonstandardized Allergenic Extracts, American Academy of Otolaryngology-Head and Neck Surgery: Instructional Courses, Vol. 1, Chapter 15, C.V. Mosby Co., St. Louis, Missouri, September 1988.

CONTAINER LABELING

GREEN PEA 
green pea injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0380
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PEA (PEA) PEA 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0380-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0380-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0380-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0380-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0380-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BLACK-EYED PEA 
black-eyed pea injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0381
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLACK-EYED PEA (BLACK-EYED PEA) BLACK-EYED PEA 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0381-1 1.0002 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0381-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0381-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0381-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0381-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PEAR 
pear injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0382
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PEAR (PEAR) PEAR 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0382-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0382-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0382-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0382-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0382-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PARSLEY 
parsley injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0377
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PARSLEY (PARSLEY) PARSLEY 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0377-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0377-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0377-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0377-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0377-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PEACH 
peach injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0378
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PEACH (PEACH) PEACH 1 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0378-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0378-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0378-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0378-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0378-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PEANUT 
peanut injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0379
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PEANUT (PEANUT) PEANUT 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0379-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0379-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0379-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0379-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0379-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
SWEET POTATO 
sweet potato injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0388
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SWEET POTATO (SWEET POTATO) SWEET POTATO 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0388-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0388-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0388-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0388-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0388-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PUMPKIN 
pumpkin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0389
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PUMPKIN (PUMPKIN) PUMPKIN 1 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
SODIUM CHLORIDE 0.0095 g  in 1 mL
Packaging
# Item Code Package Description
1 NDC:49288-0389-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0389-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0389-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0389-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0389-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PIMENTO 
pimento injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0404
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RED BELL PEPPER (RED BELL PEPPER) RED BELL PEPPER 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0404-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0404-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0404-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0404-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0404-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BLACK PEPPER 
black pepper injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0384
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLACK PEPPER (BLACK PEPPER) BLACK PEPPER 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0384-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0384-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0384-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0384-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0384-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
RED PEPPER 
red pepper injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0385
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RED BELL PEPPER (RED BELL PEPPER) RED BELL PEPPER 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0385-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0385-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0385-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0385-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0385-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
GREEN BELL PEPPER 
green bell pepper injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0386
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GREEN BELL PEPPER (GREEN BELL PEPPER) GREEN BELL PEPPER 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0386-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0386-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0386-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0386-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0386-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
MUSHROOM 
mushroom injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0305
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CULTIVATED MUSHROOM (CULTIVATED MUSHROOM) CULTIVATED MUSHROOM 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0305-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0305-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0305-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0305-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0305-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
MUSTARD SEED 
mustard seed injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0306
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUSTARD SEED (MUSTARD SEED) MUSTARD SEED 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0306-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0306-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0306-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0306-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0306-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
MUSTARD GREENS 
mustard greens injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0316
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUSTARD GREENS (MUSTARD GREENS) MUSTARD GREENS 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0316-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0316-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0316-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0316-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0316-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
HONEYDEW MELON 
honeydew melon injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0300
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HONEYDEW MELON (HONEYDEW MELON) HONEYDEW MELON 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0300-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0300-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0300-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0300-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0300-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
MILLET 
millet injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0303
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MILLET SEED (MILLET SEED) MILLET SEED 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0303-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0303-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0303-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0303-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0303-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
MINT 
mint injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0304
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SPEARMINT (SPEARMINT) SPEARMINT 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0304-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0304-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0304-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0304-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0304-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
NUTMEG 
nutmeg injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0329
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NUTMEG (NUTMEG) NUTMEG 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0329-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0329-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0329-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0329-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0329-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
OLIVE 
olive injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0345
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GREEN OLIVE (GREEN OLIVE) GREEN OLIVE 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0345-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0345-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0345-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0345-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0345-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
POTATO 
potato injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0374
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTATO (POTATO) POTATO 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0374-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0374-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0374-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0374-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0374-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PAPRIKA 
paprika injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0376
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAPRIKA (PAPRIKA) PAPRIKA 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0376-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0376-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0376-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0376-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0376-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
ORANGE 
orange injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0333
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ORANGE (ORANGE) ORANGE 1 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0333-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0333-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0333-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0333-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0333-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
WHOLE GRAIN OAT 
whole grain oat injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0334
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OAT (OAT) OAT 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0334-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0334-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0334-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0334-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0334-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
ONION 
onion injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0335
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ONION (ONION) ONION 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0335-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0335-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0335-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0335-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0335-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PINEAPPLE 
pineapple injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0405
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PINEAPPLE (PINEAPPLE) PINEAPPLE 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0405-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0405-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0405-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0405-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0405-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
THYME 
thyme injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0572
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GARDEN THYME (GARDEN THYME) GARDEN THYME 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0572-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0572-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0572-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0572-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0572-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
VANILLA BEAN 
vanilla bean injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0591
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VANILLA (VANILLA) VANILLA 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0591-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0591-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0591-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0591-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0591-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
WHOLE WHEAT 
whole wheat injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0595
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WHEAT (WHEAT) WHEAT 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0595-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0595-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0595-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0595-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0595-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
TOMATO 
tomato injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0565
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOMATO (TOMATO) TOMATO 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0565-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0565-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0565-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0565-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0565-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
TAPIOCA 
tapioca injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0566
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STARCH, TAPIOCA (STARCH, TAPIOCA) STARCH, TAPIOCA 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0566-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0566-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0566-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0566-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0566-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
TURNIP 
turnip injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0571
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TURNIP (TURNIP) TURNIP 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0571-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0571-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0571-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0571-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0571-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
ENGLISH WALNUT MEAT 
english walnut meat injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0596
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENGLISH WALNUT (ENGLISH WALNUT) ENGLISH WALNUT 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0596-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0596-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0596-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0596-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0596-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
GRAPEFRUIT 
grapefruit injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0223
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GRAPEFRUIT (GRAPEFRUIT) GRAPEFRUIT 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 0.0095 g  in 1 mL
GLYCERIN 0.525 mL  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0223-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0223-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0223-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0223-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0223-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PLUM 
plum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0407
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLUM (PLUM) PLUM 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0407-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0407-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0407-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0407-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0407-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
RASPBERRY 
raspberry injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0440
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RASPBERRY (RASPBERRY) RASPBERRY 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0440-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0440-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0440-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0440-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0440-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BLACK WALNUT MEAT 
black walnut meat injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0597
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLACK WALNUT (BLACK WALNUT) BLACK WALNUT 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0597-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0597-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0597-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0597-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0597-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
WATERMELON 
watermelon injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0598
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATERMELON (WATERMELON) WATERMELON 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0598-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0598-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0598-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0598-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0598-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BREWERS YEAST 
brewers yeast injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0617
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SACCHAROMYCES CEREVISIAE (SACCHAROMYCES CEREVISIAE) SACCHAROMYCES CEREVISIAE 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0617-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0617-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0617-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0617-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0617-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
RASPBERRY 
raspberry injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0439
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RASPBERRY (RASPBERRY) RASPBERRY 1 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0439-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0439-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0439-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0439-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0439-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
RICE 
rice injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0441
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RICE (RICE) RICE 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0441-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0441-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0441-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0441-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0441-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
RYE 
rye injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0442
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RYE (RYE) RYE 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0442-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0442-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0442-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0442-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0442-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PLUM 
plum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0406
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLUM (PLUM) PLUM 1 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0406-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0406-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0406-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0406-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0406-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BAKERS YEAST 
bakers yeast injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0429
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SACCHAROMYCES CEREVISIAE (SACCHAROMYCES CEREVISIAE) SACCHAROMYCES CEREVISIAE 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0429-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0429-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0429-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0429-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0429-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
RADISH 
radish injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0438
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RAPHANUS SATIVUS (RAPHANUS SATIVUS) RAPHANUS SATIVUS 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0438-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0438-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0438-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0438-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0438-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
SAFFLOWER SEED 
safflower seed injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0474
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SAFFLOWER (SAFFLOWER) SAFFLOWER 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0474-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0474-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0474-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0474-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0474-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
SUGAR BEET 
sugar beet injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0481
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BEET (BEET) BEET 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0481-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0481-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0481-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0481-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0481-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
SUNFLOWER SEED 
sunflower seed injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0483
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUNFLOWER SEED (SUNFLOWER SEED) SUNFLOWER SEED 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0483-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0483-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0483-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0483-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0483-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
SAGE 
sage injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0493
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALVIA OFFICINALIS (SALVIA OFFICINALIS) SALVIA OFFICINALIS 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0493-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0493-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0493-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0493-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0493-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
SESAME SEED 
sesame seed injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0475
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SESAME SEED (SESAME SEED) SESAME SEED 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0475-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0475-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0475-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0475-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0475-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
SPINACH 
spinach injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0479
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SPINACH (SPINACH) SPINACH 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0479-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0479-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0479-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0479-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0479-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
STRAWBERRY 
strawberry injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0480
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STRAWBERRY (STRAWBERRY) STRAWBERRY 1 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0480-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0480-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0480-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0480-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0480-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
MALT 
malt injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0292
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MALT EXTRACT, BARLEY (MALT EXTRACT, BARLEY) MALT EXTRACT, BARLEY 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0292-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0292-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0292-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0292-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0292-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BUCKWHEAT 
buckwheat injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0051
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUCKWHEAT (BUCKWHEAT) BUCKWHEAT 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0051-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0051-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0051-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0051-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0051-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BEET 
beet injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0052
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BEET (BEET) BEET 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0052-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0052-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0052-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0052-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0052-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BRAZIL NUT MEAT 
brazil nut meat injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0053
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BRAZIL NUT (BRAZIL NUT) BRAZIL NUT 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0053-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0053-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0053-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0053-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0053-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
SOYBEAN 
soybean injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0048
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOYBEAN (SOYBEAN) SOYBEAN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0048-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0048-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0048-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0048-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0048-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BROCCOLI 
broccoli injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0049
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROCCOLI (BROCCOLI) BROCCOLI 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0049-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0049-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0049-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0049-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0049-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BRUSSELS SPROUT 
brussels sprout injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0050
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BRUSSELS SPROUT (BRUSSELS SPROUT) BRUSSELS SPROUT 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0050-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0050-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0050-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0050-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0050-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BLACKBERRY 
blackberry injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0054
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLACKBERRY (BLACKBERRY) BLACKBERRY 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0054-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0054-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0054-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0054-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0054-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CORN 
corn injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0099
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CORN (CORN) CORN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0099-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0099-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0099-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0099-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0099-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CABBAGE 
cabbage injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0101
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CABBAGE (CABBAGE) CABBAGE 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0101-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0101-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0101-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0101-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0101-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CANTALOUPE 
cantaloupe injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0102
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANTALOUPE (CANTALOUPE) CANTALOUPE 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0102-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0102-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0102-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0102-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0102-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BLUEBERRY 
blueberry injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0055
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLUEBERRY (BLUEBERRY) BLUEBERRY 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0055-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0055-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0055-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0055-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0055-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
KIDNEY BEAN 
kidney bean injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0061
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KIDNEY BEAN (KIDNEY BEAN) KIDNEY BEAN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0061-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0061-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0061-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0061-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0061-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BAY LEAF 
bay leaf injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0071
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAURUS NOBILIS (LAURUS NOBILIS) LAURUS NOBILIS 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0071-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0071-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0071-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0071-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0071-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
ASPARAGUS 
asparagus injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0012
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPARAGUS (ASPARAGUS) ASPARAGUS 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0012-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0012-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0012-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0012-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0012-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
AVOCADO 
avocado injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0013
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOCADO (AVOCADO) AVOCADO 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0013-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0013-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0013-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0013-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0013-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BANANA 
banana injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0040
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BANANA (BANANA) BANANA 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0040-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0040-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0040-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0040-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0040-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
ALMOND 
almond injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0009
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALMOND (ALMOND) ALMOND 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0009-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0009-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0009-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0009-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0009-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
APPLE 
apple injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0010
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
APPLE (APPLE) APPLE 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
SODIUM CHLORIDE 0.0095 g  in 1 mL
Packaging
# Item Code Package Description
1 NDC:49288-0010-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0010-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0010-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0010-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0010-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
APRICOT 
apricot injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0011
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
APRICOT (APRICOT) APRICOT 1 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0011-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0011-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0011-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0011-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0011-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BASIL 
basil injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0041
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BASIL (BASIL) BASIL 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0041-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0041-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0041-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0041-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0041-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
NAVY BEAN 
navy bean injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0045
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KIDNEY BEAN (KIDNEY BEAN) KIDNEY BEAN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0045-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0045-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0045-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0045-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0045-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PINTO BEAN 
pinto bean injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0046
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KIDNEY BEAN (KIDNEY BEAN) KIDNEY BEAN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0046-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0046-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0046-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0046-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0046-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
GREEN (STING) BEAN 
green (string) bean injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0047
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STRING BEAN (STRING BEAN) STRING BEAN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0047-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0047-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0047-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0047-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0047-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
WHOLE GRAIN BARLEY 
whole grain barley injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0042
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BARLEY (BARLEY) BARLEY 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0042-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0042-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0042-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0042-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0042-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
LIMA BEAN 
lima bean injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0043
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIMA BEAN (LIMA BEAN) LIMA BEAN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0043-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0043-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0043-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0043-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0043-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
MUNG BEAN 
mung bean injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0044
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUNG BEAN (MUNG BEAN) MUNG BEAN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0044-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0044-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0044-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0044-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0044-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CARROT 
carrot injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0104
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARROT (CARROT) CARROT 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0104-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0104-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0104-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0104-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0104-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
GARLIC 
garlic injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0218
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GARLIC (GARLIC) GARLIC 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0218-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0218-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0218-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0218-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0218-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
GINGER 
ginger injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0219
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GINGER (GINGER) GINGER 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0219-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0219-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0219-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0219-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0219-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CONCORD GRAPE 
concord grape injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0221
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CONCORD GRAPE (CONCORD GRAPE) CONCORD GRAPE 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0221-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0221-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0221-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0221-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0221-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
DILL SEED 
dill seed injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0162
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILL (DILL) DILL 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0162-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0162-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0162-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0162-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0162-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/26/1974
EGGPLANT 
eggplant injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0196
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EGGPLANT (EGGPLANT) EGGPLANT 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0196-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0196-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0196-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0196-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0196-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
FILBERT NUT MEAT 
filbert nut meat injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0199
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HAZELNUT (HAZELNUT) HAZELNUT 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0199-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0199-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0199-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0199-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0199-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
GRAPEFRUIT 
grapefruit injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0222
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GRAPEFRUIT (GRAPEFRUIT) GRAPEFRUIT 1 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 0.0095 g  in 1 mL
GLYCERIN 0.525 mL  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0222-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0222-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0222-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0222-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0222-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
LEMON 
lemon injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0288
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEMON (LEMON) LEMON 1 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0288-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0288-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0288-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0288-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0288-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
LIME 
lime injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0289
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIME (CITRUS) (LIME (CITRUS)) LIME (CITRUS) 1 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0289-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0289-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0289-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0289-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0289-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
LENTIL 
lentil injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0290
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LENTIL (LENTIL) LENTIL 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0290-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0290-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0290-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0290-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0290-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
WHITE GRAPE 
white grape injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0231
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WINE GRAPE (WINE GRAPE) WINE GRAPE 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0231-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0231-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0231-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0231-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0231-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
HOPS 
hops injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0254
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOPS (HOPS) HOPS 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0254-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0254-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0254-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0254-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0254-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
LETTUCE 
lettuce injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0286
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LETTUCE (LETTUCE) LETTUCE 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0286-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0286-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0286-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0286-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0286-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CHERRY 
cherry injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0110
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SWEET CHERRY (SWEET CHERRY) SWEET CHERRY 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0110-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0110-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0110-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0110-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0110-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CLOVE 
clove injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0112
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOVE (CLOVE) CLOVE 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0112-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0112-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0112-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0112-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0112-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CINNAMON 
cinnamon injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0114
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CINNAMON (CINNAMON) CINNAMON 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0114-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0114-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0114-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0114-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0114-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CASHEW NUT MEAT 
cashew nut meat injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0105
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CASHEW (CASHEW) CASHEW 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0105-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0105-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0105-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0105-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0105-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CAULIFLOWER 
cauliflower injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0107
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAULIFLOWER (CAULIFLOWER) CAULIFLOWER 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0107-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0107-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0107-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0107-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0107-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CELERY 
celery injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0108
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CELERY (CELERY) CELERY 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0108-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0108-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0108-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0108-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0108-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
WHOLE BEAN CACAO 
whole bean cacao injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0115
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCOA BEAN (COCOA BEAN) COCOA BEAN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0115-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0115-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0115-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0115-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0115-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CARAWAY SEED 
caraway seed injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0152
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARAWAY (CARAWAY) CARAWAY 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0152-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0152-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0152-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0152-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0152-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CUMIN 
cumin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0155
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CUMIN (CUMIN) CUMIN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0155-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0155-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0155-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0155-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0155-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
DATE 
date injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0161
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DATE (DATE) DATE 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0161-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0161-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0161-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0161-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0161-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CRANBERRY 
cranberry injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0117
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CRANBERRY (CRANBERRY) CRANBERRY 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0117-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0117-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0117-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0117-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0117-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CUCUMBER 
cucumber injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0118
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CUCUMBER (CUCUMBER) CUCUMBER 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0118-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0118-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0118-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0118-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0118-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
COCONUT 
coconut injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0120
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCONUT (COCONUT) COCONUT 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0120-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0120-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0120-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0120-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0120-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PECAN NUT MEAT 
pecan nut meat injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49288-0383
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PECAN (PECAN) PECAN 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL  in 1 mL
SODIUM CHLORIDE 0.0095 g  in 1 mL
SODIUM BICARBONATE 0.0024 g  in 1 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:49288-0383-1 2 mL in 1 VIAL, MULTI-DOSE
2 NDC:49288-0383-2 5 mL in 1 VIAL, MULTI-DOSE
3 NDC:49288-0383-3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:49288-0383-4 30 mL in 1 VIAL, MULTI-DOSE
5 NDC:49288-0383-5 50 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
Labeler - Antigen Laboratories, Inc. (030705628)
Registrant - Antigen Laboratories, Inc. (030705628)
Establishment
Name Address ID/FEI Operations
Antigen Laboratories, Inc. 030705628 manufacture
Revised: 11/2009
 
Antigen Laboratories, Inc.
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