Label: ISOTONIC SODIUM CHLORIDE- biofleks isotonic sodium chloride sterile injection

  • NDC Code(s): 85184-0001-1, 85184-0001-2, 85184-0001-3, 85184-0001-4
  • Packager: HAVER FARMA ILAC ANONIM SIRKETI
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 17, 2025

If you are a consumer or patient please visit this version.

  • GENERAL PRECAUTIONS

    ADMINISTERED INTRAVENOUSLY ASEPTICALLY. Do not use if the solution is not clear or the bag is damaged. Please read the package leaflet. Consult your doctor right away if you have any unexpected effect. It is disposable. Partially used solutions should not be stored. Keep out of reach and sight of the children and store in the original package. Store at room temperature below 25°C. Sold with prescription only.

  • PRINCIPAL DISPLAY PANEL

    biofleks
    100 mL
    0.9 % ISOTONIC
    SODIUM CHLORIDE SOLUTION
    STERILE

    Per 100 mL
    Sodium Chloride
    Water for Injection

    Electrolyte Concentrations (mEq/L)
    ADMINISTERED INTRAVENOUSLY ASEPTICALLY. Do not use if the solution is not clear or the bag is damaged. Please read the package leaflet. Consult your doctor right away if you have any unexpected effect. It is disposable. Partially used solutions should not be stored. Keep out of reach and sight of the children and store in the original package. Store at room temperature below 25°C. Sold with prescription only. Distributor: Vin Trading LLC
    Phone: (201) 676-3232 / E-Mail: info@vintradingllc.com Address: 203 Lemoine Ave #118, Fort Lee, NJ 07024
    OSEL llaç San. ve Tic. A.Ş.
    Beykoz / İstanbul / TURKEY

    100mL Bag

    100 mL

    250mL Bag

    250 mL

    500 mL Bag

    500 mL

    1000mL Bag

    1000 mL

  • INGREDIENTS AND APPEARANCE
    ISOTONIC SODIUM CHLORIDE 
    biofleks isotonic sodium chloride sterile injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:85184-0001
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, IRRIGATION
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE0.9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85184-0001-1100 mL in 1 BAG; Type 0: Not a Combination Product01/01/2025
    2NDC:85184-0001-2250 mL in 1 BAG; Type 0: Not a Combination Product01/01/2025
    3NDC:85184-0001-3500 mL in 1 BAG; Type 0: Not a Combination Product01/01/2025
    4NDC:85184-0001-41000 mL in 1 BAG; Type 0: Not a Combination Product01/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Emergency Use Authorization01/01/2025
    Labeler - HAVER FARMA ILAC ANONIM SIRKETI (365593526)
    Registrant - HAVER FARMA ILAC ANONIM SIRKETI (365593526)
    Establishment
    NameAddressID/FEIBusiness Operations
    HAVER FARMA ILAC ANONIM SIRKETI365593526manufacture(85184-0001)