FDA.reportPublic FDA data

5% Dextrose Injection, USP

Manufacturer
Baxter Healthcare Corporation | Baxter Corporation
Effective date
2017-10-13
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:11:21

Label at a glance#

ProductDextrose
Active ingredientDEXTROSE MONOHYDRATE
Label structure2 sections

Label contents#

Full prescribing information#

HEALTH CARE PROVIDER LETTER

HEALTH CARE PROVIDER LETTER SECTION

DHCP Letter 1
DHCP Letter 1
DHCP Letter 2
DHCP Letter 2
DHCP Letter 3
DHCP Letter 3
DHCP Letter 4
DHCP Letter 4
DHCP Letter 5
DHCP Letter 5
DHCP Letter 6
DHCP Letter 6
DHCP Letter 7
DHCP Letter 7
DHCP Letter 8
DHCP Letter 8
DHCP Letter 9
DHCP Letter 9
DHCP Letter 10
DHCP Letter 10
DHCP Letter 11
DHCP Letter 11
DHCP Letter 12
DHCP Letter 12
DHCP Letter 13
DHCP Letter 13
DHCP Letter 14
DHCP Letter 14
DHCP Letter 15
DHCP Letter 15
DHCP Letter 16
DHCP Letter 16
DHCP Letter 17
DHCP Letter 17

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Shortage Representative Dextrose 0338-9533-96 Container Lbl
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
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9533-96ML - Milliliter0338-9533d6bf01ef-e805-4b7a-bb55-80be84cab66612017-11-06
0338-9530-96ML - Milliliter0338-95304eadafcc-4886-467a-b7d2-2768ea2de71812017-11-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0338-95330338-9533-96
0338-95300338-9530-96

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROSE MONOHYDRATELX22YL083GACTIB
DEXTROSE MONOHYDRATELX22YL083GACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
47a9fc04-dc97-440a-b645-6163e554117cfc8844f4-e532-46b7-baee-b4b156f1add92019-11-13Exact identifier
spl set id: fc8844f4-e532-46b7-baee-b4b156f1add9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.