GLUCOSE AND SODIUM CHLORIDE- dextrose anhydrous and sodium chloride injection, solution

Glucose and Sodium Chloride by

Drug Labeling and Warnings

Glucose and Sodium Chloride 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]

HEALTH CARE PROFESSIONAL LETTER

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)

PACKAGE INSERT

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Baxter Logo Trademark

A6C1064US

GLUCOSE AND
SODIUM CHLORIDE INJECTION

100

200

300

400

500

600

700

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

INGREDIENTS AND APPEARANCE

GLUCOSE AND SODIUM CHLORIDE 
dextrose anhydrous and sodium chloride injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9799
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	5.5 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	0.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-9799-12	12 in 1 CARTON	10/11/2024
1	NDC: 0338-9799-01	1000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		10/11/2024

Labeler - Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Healthcare (Shanghai) Co. Ltd.		527191860	MANUFACTURE(0338-9799) , ANALYSIS(0338-9799) , LABEL(0338-9799) , PACK(0338-9799) , STERILIZE(0338-9799)