Label: SODIUM CHLORIDE injection

  • NDC Code(s): 0338-9517-16, 0338-9517-30, 0338-9517-50
  • Packager: Baxter Healthcare Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL

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.

Drug Label Information

Updated January 31, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Health Care Provider Letter

    Dear DHCP Letter_image 01
    Dear DHCP Letter_image 02
    Dear DHCP Letter_image 03
    Dear DHCP Letter_image 04
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Representative Container Label 500 mL

    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
    100
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    300

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    FZB1323
    28 25 01 506

  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE 
    sodium chloride injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9517
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE900 mg  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-9517-5050 in 1 CARTON01/31/2018
    1250 mL in 1 BAG; Type 0: Not a Combination Product
    2NDC:0338-9517-3030 in 1 CARTON01/31/2018
    2500 mL in 1 BAG; Type 0: Not a Combination Product
    3NDC:0338-9517-1616 in 1 CARTON01/31/2018
    31000 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 shortage01/31/2018
    Labeler - Baxter Healthcare Corporation (005083209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Hospitalar Ltda.900203175ANALYSIS(0338-9517) , MANUFACTURE(0338-9517) , LABEL(0338-9517) , PACK(0338-9517) , STERILIZE(0338-9517)