Label: DEXTROSE- dextrose monohydrate injection, solution
- NDC Code(s): 0338-9588-01, 0338-9588-12, 0338-9830-01, 0338-9830-03
- Packager: Baxter Healthcare Company
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Unapproved drug for use in drug shortage
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.
Drug Label Information
Updated November 6, 2024
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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)00809080000258APPROX mOsmol/L – 252
pH 4.0INTRAVENOUS FLUID AND NUTRI-
ENT REPLENISHIMENT / RECHARGE
LIQUIDIENNE ET NUTRIMENT PAR
INJECTION INTRAVEINEUSEPER 100 mL DEXTROSE HYDROUS
USP – 5 g / WATER FOR INJECTION
USP – qs / pH MAY BE ADJUSTED
WITH SODIUM HYDROXIDEPAR 100 mL DEXTROSE HYDRATE USP – 5 g / EAU POUR
INJECTION USP – qs / pH PEUT ETRE AJUSTE AVEC DE
L’HYDROXYDE DE SODIUMCAUTIONS 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°CATTENTIONS 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°CNONPYROGENIC / STERILE / APYROGENE
VIAFLEX® PVC CONTAINER / CONTENANT DE PVC
Baxter Logo
Baxter Corporation
Mississauga ON L5N 0C2No Latex Label
88-70-20-465
50
100
150
200
Container Label
JB0064 1000 mL DIN 00060348
5% Dextrose
Injection USPDextrose à 5%
USP, InjectableD5W
APPROX mOsmol/L – 252 pH 4.0
INTRAVENOUS FLUID AND NUTRIENT REPLENISHIMENT /
RECHARGE LIQUIDIENNE ET NUTRIMENT PAR INJECTION
INTRAVEINEUSEPER 100 mL DEXTROSE HYDROUS USP – 5 g / WATER FOR
INJECTION USP – qs / pH MAY BE ADJUSTED WITH SODIUM
HYDROXIDEPAR 100 mL DEXTROSE HYDRATE USP – 5 g / EAU POUR
INJECTION USP – qs / pH PEUT ETRE AJUSTE AVEC DE
L’HYDROXYDE DE SODIUMCAUTIONS 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°CATTENTIONS 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°CNONPYROGENIC / 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 INCBaxter Logo
Baxter Corporation
Mississauga ON L5N 0C2No Latex Label
07-25-77-316
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INGREDIENTS AND APPEARANCE
DEXTROSE
dextrose monohydrate injection, solutionProduct 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, solutionProduct 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)
