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Glucose and Sodium Chloride Injection: Package Insert / Prescribing Info

Package insert / product label
Generic name: dextrose anhydrous and sodium chloride
Dosage form: injection, solution
J Code (medical billing code): J7042 (500 mL = 1 unit, intravenous)

Medically reviewed by Drugs.com. Last updated on Feb 3, 2025.

HEALTH CARE PROFESSIONAL LETTER

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Reporting Adverse Events or Product Quality Issues
To report adverse events associated with these imported products, please call Baxter at 1-866-888-2472, or fax: 1- 800-759-1801. Adverse events or quality problems experienced with the use of these imported products may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax:
• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

To report product quality issues associated with these imported products, please contact Baxter Product Surveillance through Baxter - Product Feedback Portal (https://productfeedback.baxter.com/).

Please also refer to the local prescribing information of the imported product, translated into English, available for:
• 0.9% Sodium Chloride Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723233)
• 5% Glucose Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723235)
• 10% Glucose Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723237)
• 5% Glucose/0.9% Sodium Chloride Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723238)

Please refer to the FDA-approved prescribing information for each drug product listed below:
• 0.9% Sodium Chloride Injection USP (click https://www.dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=f55bd888-5e01-474d-871b-24654c070178&type=pdf&name=f55bd888-5e01-474d-871b-24654c070178)
• 5% Dextrose Injection USP (click https://www.dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5&type=pdf&name=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5)
• 10% Dextrose Injection USP (click https://www.dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5&type=pdf&name=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5)
• 5% Dextrose/0.9% Sodium Chloride Injection USP (click https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016678s007,016683s103,016687s104,016689s107,016697s098lbl.pdf)

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PACKAGE INSERT

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

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Baxter Logo Trademark

A6C1064US

GLUCOSE AND
SODIUM CHLORIDE INJECTION

100

200

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400

500

600

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800

900

1000ml
5% GLUCOSE
0.9% SODIUM CHLORIDE

[Strength] 1000ml: glucose 50g
and sodium chloride 9g
[Description] This product is a clear, colorless liquid
[Dosage and Administration] Intravenous drip See the
package insert for details
For details of [Indications], [Adverse Reactions],
[Contraindications], and [Precautions], please refer to the
package insert

[Storage] Store in overwrap

The solution should be clear and should be used
up at one time
Inspect the inner bag by squeezing it and discard
solution if leakage occurs
License Number: H19994068

AA

[Drug Marketing Authorization Holder] [Manufacturer]
Name: Baxter Healthcare (Shanghai) Co., Ltd.
Address: No. 388, Tingzhu Road, Jinshan District, Shanghai

BarCode
(01) 00303389799016

LOT
MFG
EXP

5% Glucose/0.9% Sodium Chloride Injection

1000ml X 12

LOT S0000000 EXP YYYY-MM
A6C1064US 1C/N LIC H19994068

5% Glucose/0.9% Sodium Chloride Injection

1000ml X 12

LOT S0000000 EXP YYYY-MM
MFG YYYY-MM-DD 1C/N 0000

GLUCOSE AND SODIUM CHLORIDE
dextrose anhydrous and sodium chloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9799
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE5.5 g in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE0.9 g in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0338-9799-1212 in 1 CARTON10/11/2024
1NDC:0338-9799-011000 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug for use in drug shortage10/11/2024
Labeler - Baxter Healthcare Corporation (005083209)
Establishment
NameAddressID/FEIBusiness Operations
Baxter Healthcare (Shanghai) Co. Ltd.527191860MANUFACTURE(0338-9799) , ANALYSIS(0338-9799) , LABEL(0338-9799) , PACK(0338-9799) , STERILIZE(0338-9799)

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