DEXTROSE- dextrose monohydrate injection, solution

Dextrose by

Drug Labeling and Warnings

Dextrose by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Company, Baxter Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Health Care Provider Letter

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Container Label

JB0062 250 mL DIN 00060348

5% Dextrose Injection USP

Dextrose à 5% USP, Injectable

D5W

2D Barcode
(01)00809080000258

APPROX mOsmol/L – 252
pH 4.0

INTRAVENOUS FLUID AND NUTRI-
ENT REPLENISHIMENT / RECHARGE
LIQUIDIENNE ET NUTRIMENT PAR
INJECTION INTRAVEINEUSE

PER 100 mL DEXTROSE HYDROUS
USP – 5 g / WATER FOR INJECTION
USP – qs / pH MAY BE ADJUSTED
WITH SODIUM HYDROXIDE

PAR 100 mL DEXTROSE HYDRATE USP – 5 g / EAU POUR
INJECTION USP – qs / pH PEUT ETRE AJUSTE AVEC DE
L’HYDROXYDE DE SODIUM

CAUTIONS SINGLE USE / DISCARD UNUSED PORTION
/ SQUEEZE AND INSPECT BAG / SEE DIRECTIONS FOR
USE / MUST NOT BE USED IN SERIES CONNECTIONS /
DO NOT ADMINISTER SIMULTANEOUSLY WITH BLOOD /
STORE AT 15°C TO 25°C

ATTENTIONS USAGE UNIQUE / JETER PORTION INTUI-
LISEE / PRESSER ET INSPECTOR LE SAC / VOIR MODE
D’EMPLOI / NE DOIT PAS ETRE MONTE EN SERIE / NE PAS
ADMINISTRER SIMULTANEMENT AVEC LA SANG / GARDER
ENTRE 15°C ET 25°C

NONPYROGENIC / STERILE / APYROGENE

VIAFLEX® PVC CONTAINER / CONTENANT DE PVC

Baxter Logo
Baxter Corporation
Mississauga ON L5N 0C2

No Latex Label

88-70-20-465

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150

200

Container Label

JB0064 1000 mL DIN 00060348

5% Dextrose
Injection USP

Dextrose à 5%
USP, Injectable

D5W

APPROX mOsmol/L – 252 pH 4.0

INTRAVENOUS FLUID AND NUTRIENT REPLENISHIMENT /
RECHARGE LIQUIDIENNE ET NUTRIMENT PAR INJECTION
INTRAVEINEUSE

PER 100 mL DEXTROSE HYDROUS USP – 5 g / WATER FOR
INJECTION USP – qs / pH MAY BE ADJUSTED WITH SODIUM
HYDROXIDE

PAR 100 mL DEXTROSE HYDRATE USP – 5 g / EAU POUR
INJECTION USP – qs / pH PEUT ETRE AJUSTE AVEC DE
L’HYDROXYDE DE SODIUM

CAUTIONS SINGLE USE / DISCARD UNUSED PORTION
SQUEEZE AND INSPECT BAG / SEE DIRECTIONS FOR USE
MUST NOT BE USED IN SERIES CONNECTIONS / DO NOT
ADMINISTER SIMULTANEOUSLY WITH BLOOD / STORE AT
15°C TO 25°C

ATTENTIONS USAGE UNIQUE / JETER PORTION INTUILISEE
PRESSER ET INSPECTOR LE SAC / VOIR MODE D’EMPLOI NE
DOIT PAS ETRE MONTE EN SERIE / NE PAS ADMINISTRER
SIMULTANEMENT AVEC LA SANG / GARDER ENTRE 15°C
ET 25°C

NONPYROGENIC / STERILE / APYROGENE

VIAFLEX PVC CONTAINER / CONTENANT DE PVC

BAXTER AND VIAFLEX ARE TRADEMARKS OF BAXTER INTERNATIONAL INC
BAXTER ET VIAFLEX SONT DES MARQUES DE COMMERCE DE BAXTER
INTERNATIONAL INC

Baxter Logo
Baxter Corporation
Mississauga ON L5N 0C2

No Latex Label

07-25-77-316

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INGREDIENTS AND APPEARANCE

DEXTROSE 
dextrose monohydrate injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9830
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	50 g  in 1000 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-9830-03	30 in 1 CARTON	11/06/2024
1	NDC: 0338-9830-01	250 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		11/06/2024

DEXTROSE 
dextrose monohydrate injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9588
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	50 g  in 1000 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-9588-12	12 in 1 CARTON	11/06/2024
1	NDC: 0338-9588-01	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		11/06/2024

Labeler - Baxter Healthcare Company (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Corporation		205087968	ANALYSIS(0338-9830, 0338-9588) , LABEL(0338-9830, 0338-9588) , MANUFACTURE(0338-9830, 0338-9588) , STERILIZE(0338-9830, 0338-9588) , PACK(0338-9830, 0338-9588)