Label: SODIUM CHLORIDE- sodium chloride injection injection, solution

  • NDC Code(s): 85036-100-01, 85036-100-02
  • Packager: Vin Trading LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 13, 2024

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  • COMPONENTS

    1000ml

    SODIUM CHLORIDE 0.9%

    Isotonic Solution for Infusion UPS

    Sterile, nonpyrogenic, Single unit container. Discard unused portion.

    Recommended storage. Store at 20-25*C (66-77*F)

    Avoid excessive heat. Protect from freezing

    Composition:

    Each 100ml contains...0.9% (m/v-w/v)

    Water for Injection..........................q.s.

    Electrolytes (mEq/liter)

    Na+ 150 CI 150

  • USER SAFETY WARNINGS

    Caution:

    FOR INTRAVENOUS INFUSION ONLY

    Not to be used if container is found leaking or solution is not clear.

    Solution containing visible solid particles should not be used.

    Any portion of the contents remaining should be discarded.

    For use under medical supervision.

  • STORAGE AND HANDLING

    Sterile, nonpyrogenic, Single unit container. Discard unused portion.

    Recommended storage. Store at 20-25*C (66-77*F)

    Avoid excessive heat. Protect from freezing

  • PRINCIPAL DISPLAY PANEL

    Carton.jpg

  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE 
    sodium chloride injection injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:85036-100
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE9 g  in 991 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85036-100-0212 in 1 CARTON12/10/2024
    1NDC:85036-100-011000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/10/2024
    Labeler - Vin Trading LLC (120880762)
    Registrant - Shijiazhuang No 4 Parmaceutical CO Ltd. (420783779)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shijiazhuang No 4 Pharmaceutical CO Ltd420783779manufacture(85036-100)
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