5% Dextrose Injection, USP In MINI-BAG Plus Container VIAFLEX Plastic Container

Dextrose by

Drug Labeling and Warnings

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

Drug Details [pdf]

DEXTROSE- dextrose monohydrate injection 
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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5% Dextrose Injection, USP
In MINI-BAG Plus Container
VIAFLEX Plastic Container

HEALTH CARE PROVIDER LETTER

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

JB0040
50 mL
DIN 00060348
Mini-Bag Plus
5% Dextrose Injection USP

Bar Code
(01)00809080000944

APPROX mOsmol/L 252 pH 4.0 SINGLE DOSE / DOSAGE UNIQUE
PER/PAR 50 mL DEXTROSE HYDROUS USP / DEXTROSE HYDRATE USP –
2.5 g pH MAY BE ADJUSTED WITH SODIUM HYDROXIDE / IV FLUID NUTRI-
ENT REPLENISHER / DIRECTION SHEET AVAILABLE UPON REQUEST /
MUST NOT BE USED IN SERIES CONNECTIONS/ DO NOT ADMINISTER
SIMULTANEOUSLY WITH BLOOD / SQUEEZE AND INSPECT BAG / DISCARD
IF LEAKING / STORE AT 15ºC TO 25º C
pH PEUT ETRE AJUSTE AVEC DE L’HYDROXYDE DE SODIUM / SOLUTION IV POUR NUTRITION
PARENTERALE / FEUILLE DE MODE D’EMPLOI DISPONIBLE SUR DEMANDE / NE DOIT PAS ETRE
MONTE EN SERIE / NE PAS ADMINISTRER SIMULTANEMENT AVEC LE SANG / PRESSER ET
INSPECTER LE SAC / JETER EN CAS DE FUITES / GARDER ENTRE 15ºC ET 25 ºC
NONPYROGENIC / STERILE / APYROGENE
Viaflex® PVC CONTAINER / CONTENANT DE PVC

ACTIVATE BEFORE USE
ACTIVER AVANT D’UTILISER

Baxter Logo
Baxter Corporation
Mississauga ON L5N 0C2

No Latex Symbol
88-70-20-290

JB0041
100 Ml
DIN 00060348
Mini-Bag Plus
5% Dextrose Injection USP

Bar Code
(01)00809080000951

APPROX mOsmol/L 252 pH 4.0
SINGLE DOSE / DOSAGE UNIQUE
PER/PAR 100 mL DEXTROSE HYDROUS USP / DEX-
TROSE HYDRATE USP – 5 g pH MAY BE ADJUSTED
WITH SODIUM HYDROXIDE / IV FLUID NUTRIENT
REPLENISHER / DIRECTION SHEET AVAILABLE UPON
REQUEST / MUST NOT BE USED IN SERIES CONNECTIONS/ DO NOT
ADMINISTER SIMULTANEOUSLY WITH BLOOD / SQUEEZE AND INSPECT
BAG / DISCARD IF LEAKING / STORE AT 15ºC TO 25º C
pH PEUT ETRE AJUSTE AVEC DE L’HYDROXYDE DE SODIUM /
SOLUTION IV POUR NUTRITION PARENTERALE / FEUILLE DE MODE
D’EMPLOI DISPONIBLE SUR DEMANDE / NE DOIT PAS ETRE MONTE
EN SERIE / NE PAS ADMINISTRER SIMULTANEMENT AVEC LE SANG /
PRESSER ET INSPECTER LE SAC / JETER EN CAS DE FUITES /
GARDER ENTRE 15ºC ET 25 ºC
NONPYROGENIC / STERILE / APYROGENE
Viaflex® PVC CONTAINER / CONTENANT DE PVC

ACTIVATE BEFORE USE
ACTIVER AVANT D’UTILISER

Baxter Logo
Baxter Corporation
Mississauga ON L5N 0C2

No Latex Symbol
88-70-20-292

DEXTROSE 
dextrose monohydrate injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9536
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	2.5 g  in 50 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-9536-96	96 in 1 CARTON	10/13/2017	10/13/2017
1		50 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		10/13/2017	10/13/2017

DEXTROSE 
dextrose monohydrate injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9539
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 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-9539-72	72 in 1 CARTON	10/13/2017	10/13/2017
1		100 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		10/13/2017	10/13/2017

Labeler - Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Corporation		205087968	ANALYSIS(0338-9536, 0338-9539) , MANUFACTURE(0338-9536, 0338-9539) , LABEL(0338-9536, 0338-9539) , PACK(0338-9536, 0338-9539) , STERILIZE(0338-9536, 0338-9539)

Revised: 11/2019

Document Id: f68ea7e3-76de-4d0f-9322-4853a711877f

34391-3

Set id: 9904f73f-525a-42ac-86ff-8ad2d4fd3a1f

Version: 2

Effective Time: 20191113

 

Baxter Healthcare Corporation