SODIUM CHLORIDE injection

SODIUM CHLORIDE by

Drug Labeling and Warnings

SODIUM CHLORIDE by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Corporation, Baxter Hospitalar Ltda.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Health Care Provider Letter

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

BATCH
EXP
0.9% SODIUM CHLORIDE
500 mL
VIAFLEX
CLOSURE SYSTEM
STORE AT ROOM TEMPERATURE (15°C TO 30°C)
ADULT AND PEDIATRIC USE
EACH 100ML CONTAINS
SODIUM CHLORIDE 900MG WATER FOR INJECTION SUFFICIENT
QUANTITY TO 100ML SODIUM 154 MEQ/L CHLORIDE 154 MEQ/L
pH APPROX 5.0 OSMOLARITY APPROX 308 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 Logo
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 1068300690198
TECHNICAL RESPONSIBLE: LUIZ GUSTAVO TANCSIK CRF 67982
CUSTOMER SERVICE 08000125522
BAXTER AND VIAFLEX ARE BRANDS OF BAXTER INTERNATIONAL INC
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FZB1323
28 25 01 506

INGREDIENTS AND APPEARANCE

SODIUM CHLORIDE 
sodium chloride injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9517
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	900 mg  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-9517-50	50 in 1 CARTON	01/31/2018
1		250 mL in 1 BAG; Type 0: Not a Combination Product
2	NDC: 0338-9517-30	30 in 1 CARTON	01/31/2018
2		500 mL in 1 BAG; Type 0: Not a Combination Product
3	NDC: 0338-9517-16	16 in 1 CARTON	01/31/2018
3		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		01/31/2018

Labeler - Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Hospitalar Ltda.		900203175	ANALYSIS(0338-9517) , MANUFACTURE(0338-9517) , LABEL(0338-9517) , PACK(0338-9517) , STERILIZE(0338-9517)