FDA.reportPublic FDA data

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

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 01:11:16

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 Dextrose Mini-Bag Representative Container Lbl
Drug Shortage Dextrose Mini-Bag Representative Container Lbl

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

Drug Shortage Dextrose Mini-Bag Representative Container Lbl
Drug Shortage Dextrose Mini-Bag Representative Container Lbl

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9536-96ML - Milliliter0338-9536e5b11bc4-b14b-4064-b7d1-df696e03605212017-11-06
0338-9539-72ML - Milliliter0338-9539c8011fb2-9b42-4d91-b6c3-396bc1c29cf512017-11-06

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
0338-95360338-9536-96
0338-95390338-9539-72

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
f68ea7e3-76de-4d0f-9322-4853a711877f9904f73f-525a-42ac-86ff-8ad2d4fd3a1f2019-11-13Exact identifier
spl set id: 9904f73f-525a-42ac-86ff-8ad2d4fd3a1f

Reported adverse events (FAERS/openFDA)#

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