10% GLUCOSE INJECTION

Glucose by

Drug Labeling and Warnings

Glucose by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Corporation, Baxter Healthcare (Shanghai) Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GLUCOSE- dextrose anhydrous injection, solution 
Baxter Healthcare Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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10% GLUCOSE INJECTION

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.fda.report/dailymed/getFile.cfm?setid=f55bd888-5e01-474d-871b-24654c070178&type=pdf/f55bd888-5e01-474d-871b-24654c070178)
5% Dextrose Injection USP (click https://www.fda.report/dailymed/getFile.cfm?setid=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5&type=pdf/3bb406a9-f5cb-403a-b1bb-5c4facbea3d5)
10% Dextrose Injection USP (click https://www.fda.report/dailymed/getFile.cfm?setid=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5&type=pdf/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

A6C0162US

GLUCOSE INJECTION

50

100

150

200

250ml
10% GLUCOSE

[Strength] 250ml: 25g
[Description] This product is a colorless or almost
colorless clear 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: H19994063

AA

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

BarCode
(01) 00303389797012

LOT
MFG
EXP

10% Glucose Injection

250ml X 40

LOT S0000000 EXP YYYY-MM
A6C0162US 1C/N LIC H19994063

10% Glucose Injection

250ml X 40

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

GLUCOSE 
dextrose anhydrous injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0338-9797
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE110 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0338-9797-4040 in 1 CARTON10/11/202404/08/2025
1NDC: 0338-9797-01250 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 shortage10/11/202404/08/2025
Labeler - Baxter Healthcare Corporation (005083209)
Establishment
NameAddressID/FEIBusiness Operations
Baxter Healthcare (Shanghai) Co. Ltd.527191860MANUFACTURE(0338-9797) , ANALYSIS(0338-9797) , LABEL(0338-9797) , PACK(0338-9797) , STERILIZE(0338-9797)

Revised: 1/2025
 

Trademark Results [Glucose]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GLUCOSE
GLUCOSE
78764828 not registered Dead/Abandoned
Glucose Media, Inc.
2005-12-01

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