D&C Red No. 28
Excipient (pharmacologically inactive substance)
What is it?
D&C Red No. 28, also known as Disodium 2',4',5',7'-tetrabromo-4,5,6,7-tetrachlorofluorescein (C20H2O5Br4Cl4Na2) is a dye approved by the FDA for use in drugs and cosmetics according to the specifications set forth by the FDA.[1] FD&C Red No. 28 is not approved for use in foods.
FDA performs regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. These colors are then certified by the FDA for safe use according to specifications. The FD&C notation specifies the color is approved for use in foods, drugs and cosmetics.[1][2]
[1] U.S. Food and Drug Administration. Color Additives: FDA's Regulatory Process and Historical Perspectives. Accessed 10/20/2011. http://www.fda.gov/ForIndustry/ColorAdditives/RegulatoryProcessHistoricalPerspectives/default.htm
[2] Electronic Code of Federal Registers. Title 21: Food and Drugs. Part 74. Listing of color additives subject to certification. Subpart B. Drugs. Accessed online October 19, 2011. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr;sid=c387334e82029536a53dde1171ba5481;rgn=div5;view=text;node=21%3A1.0.1.1.27;idno=21;cc=ecfr#21:1.0.1.1.27.2.31.35
Top Medications with this excipient
- Amlodipine Besylate and Benazepril Hydrochloride 5 mg / 20 mg (Sandoz Inc.)
- Amlodipine Besylate and Benazepril Hydrochloride 5 mg / 20 mg (Dr. Reddy’s Laboratories Inc.)
- Amoxicillin Trihydrate 500mg (Aurobindo Pharma)
- Ampicillin 500 mg (Pharma Pac)
- Ampicillin 250 mg (Dava Pharmaceuticals Inc.)
- Cefdinir 300 mg (Lupin Pharmaceuticals, Inc)
- Clindamycin Hydrochloride 300 mg (Watson Pharmaceuticals)
- Dicyclomine Hydrochloride 10 mg (Watson Laboratories, Inc.)
- Doxycycline Hyclate 100 mg (Sun Pharmaceutical Industries Inc.)
- Fluoxetine Hydrochloride and Olanzapine 50 mg / 12 mg (Par Pharmaceutical)
- Fluoxetine Hydrochloride and Olanzapine 50 mg / 6 mg (Sandoz Inc.)
- Hydroxyzine Pamoate 25 mg (Teva Pharmaceuticals USA)
- Minipress 1 mg (Pfizer U.S. Pharmaceuticals Group)
- Omeprazole Delayed Release 20 mg (Dr. Reddy’s Laboratories Inc.)
- Tacrolimus 5 mg (Mylan Pharmaceuticals Inc.)
- Tacrolimus 0.5 mg (Mylan Pharmaceuticals Inc.)
- Terazosin Hydrochloride 2 mg (Mylan Pharmaceuticals Inc.)
- Terazosin Hydrochloride 5 mg (Mylan Pharmaceuticals Inc.)
- Vancomycin Hydrochloride 125 mg (base) (Alvogen Inc)
- Venlafaxine Hydrochloride Extended Release 37.5 mg (Wockhardt USA LLC.)
