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

HEALTH CARE PROVIDER LETTER

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Drug Shortage Representative Dextrose 0338-9533-96 Container Lbl

JB0081
50 mL
DIN 00060348
5% Dextrose Injection USP

Bar Code
(01)00809080000999

APPROX mOsmol/L 252 pH 4.0
SINGLE DOSE / DOSAGE UNIQUE
PER/PAR mL DEXTROSE HYDROUS USP /
DEXTROSE HYDRATE USP – 50 mg pH MAY
BE ADJUSTED WITH SODIUM HYDROXIDE /
IV FLUID NUTRIENT REPLENISHER / USE AS
PRESCRIBED / DIRECTION SHEET AVAILABLE
UPON REQUEST / SQUEEZE AND INSPECT
BAG / DISCARD IF LEAKING / MUST NOT BE
USED IN SERIES CONNECTIONS / DO NOT
ADMINISTER SIMULTANEOUSLY WITH BLOOD /
STORE AT 15ºC TO 25º C

Ph PEUT ETRE ADJUSTE AVEC DE L’HYDROXYDE DE SODIUM / SO-
LUTION IV POUR NUTRITION PARENTERALE / ADMINISTRER TEL
QUE PRESCRIT PAR LE MEDECIN / FEUILLE DE MODE D’EMPLOI
DISPONIBLE SUR DEMANDE / PRESSER ET INSPECTER LE SAC /
JETER EN CAS DE FUITES / NE DOIT PAS ETRE MONTE EN SERIE /
NE PAS ADMINISTRER SIMULTANEMENT AVEC LE SANG /
GARDER ENTRE 15ºC ET 25 ºC
NONPYROGENIC / STERILE / APYROGENE
VIAFLEX® PVC CONTAINER / CONTENANT DE PVC

Baxter Logo
Baxter Corporation Mississauga ON L5N 0C2

No Latex Symbol
88-70-20-274

Drug Shortage Dextrose 0338-9530-96 Representative Container Lbl

JB0082
100 mL
DIN 00060348
5% Dextrose Injection USP

Bar Code
(01)00809080001002

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

Baxter Logo
Baxter Corporation Mississauga ON L5N 0C2

No Latex Symbol
88-70-20-275

DEXTROSE 
dextrose monohydrate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9533
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE50 mg  in 50 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0338-9533-9696 in 1 CARTON10/13/201710/13/2017
150 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 shortage10/13/201710/13/2017
DEXTROSE 
dextrose monohydrate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9530
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE50 mg  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0338-9530-9696 in 1 CARTON10/13/201710/13/2017
1100 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 shortage10/13/201710/13/2017
Labeler - Baxter Healthcare Corporation (005083209)
Establishment
NameAddressID/FEIBusiness Operations
Baxter Corporation205087968ANALYSIS(0338-9533, 0338-9530) , MANUFACTURE(0338-9533, 0338-9530) , LABEL(0338-9533, 0338-9530) , PACK(0338-9533, 0338-9530) , STERILIZE(0338-9533, 0338-9530)

Revised: 11/2019
Document Id: 47a9fc04-dc97-440a-b645-6163e554117c
Set id: fc8844f4-e532-46b7-baee-b4b156f1add9
Version: 2
Effective Time: 20191113
 
Baxter Healthcare Corporation