5% Dextrose Injection

Drug Labeling and Warnings

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

Health Care Provider Letter

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

BATCH
EXP
5% DEXTROSE INJECTION
100mL
VIAFLEX
CLOSURE SYSTEM
STORE AT ROOM TEMPERATURE (15°C TO 30°C)
ADULT AND PEDIATRIC USE EACH 100ML CONTAINS
DEXTROSE HYDROUS 5G WATER FOR INJECTION SUFFICIENT
QUANTITY TO 100ML
pH APPROX 4.0 OSMOLARITY APPROX 252 mOsml/L
INTRAVENOUS ADMINISTRATION STERILE NONPYROGENIC
SOLUTION DO NOT USE IF TURBIDITY IS PRESENT SINGLE USE
DISCARD AFTER USE INFORMATION TO THE HEALTHCARE
PROFESSIONAL INDICATIONS CONTRAINDICATIONS AND
PRECAUTIONS REFER TO PACKAGE INSERT ALL MEDICINES
SHOULD BE KEPT OUT OF THE REACH OF CHILDREN
REMOVE THE OVERPOUCH FOR USE LATEX FREE PRODUCT
RESTRICTED USE FOR HOSPITALS SALE UNDER MEDICAL
PRESCRIPTION
BAXTER
BAXTER HOSPITALAR LTDA
HENRI DUNANT STREET 1383 12º FLOOR TOWER B
CONJ 1201 E 1204 SÃO PAULO SP BRAZIL
CNPJ 49351786000180 BRAZILIAN INDUSTRY
LICENSE NUMBER 1068300700282
TECHNICAL RESPONSIBLE: LUIZ GUSTAVO TANCSIK CRF 67982
CUSTOMER SERVICE 08000125522
BAXTER AND VIAFLEX ARE BRANDS OF BAXTER INTERNATIONAL INC
PRINTED IN BRAZIL
25
50
75
28 25 01 499
FZB0087

DEXTROSE 
dextrose monohydrate injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9523
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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-9523-72	72 in 1 CARTON	01/15/2018	07/24/2019
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		01/15/2018	07/24/2019

Labeler - Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Hospitalar Ltda.		900203175	ANALYSIS(0338-9523) , MANUFACTURE(0338-9523) , LABEL(0338-9523) , PACK(0338-9523) , STERILIZE(0338-9523)

Revised: 7/2019

Document Id: a91d98dd-e8b2-4d99-88d9-84802c5f1e4e

34391-3

Set id: 54869f91-4d0e-4b2c-a818-ab899a252934

Version: 3

Effective Time: 20190724

 

Baxter Healthcare Corporation