HEPARIN SODIUM INJECTION, SOLUTION [CANTRELL DRUG COMPANY]

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HEPARIN SODIUM INJECTION, SOLUTION [CANTRELL DRUG COMPANY]
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NDC 52533-179-18
Set ID 4882ba55-d741-4636-a3c3-866630191a65
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Cantrell Drug Company
Generic Name
Product Class Anti-coagulant
Product Number
Application Number
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  • PRINCIPAL DISPLAY PANEL

    Label

  • • WARNINGS AND PRECAUTIONS

    Outsourced Compounded Drug. Not for Resale. Hospital/Office Use Only.

  • • ADVERSE EVENTS

    To facilitate Adverse Event Reporting: www.fda.gov/medwatch or 1-800-FDA-1088.

  • • HOW SUPPLIED

    Contains 25,000 USP Units of Heparin Sodium in 0.45% Sodium Chloride in a 250 mL Single-Dose Bag.  Volume & Concentration exlude additive & manufacturer overfill.

    This product is Sterile, Nonpyrogenic, and Latex Free.

  • • INGREDIENTS

    Each 1 mL contains contains Heparin Sodium 100 USP Units, Sodium Chloride 4.5 mg, Benzyl Alcohol 0.0002 mL. May contain Hydrochloric Acid and/or Sodium Hydroxide for pH adjustment.

  • • STORAGE AND HANDLING

    Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. 

  • • DOSAGE AND ADMINISTRATION.

    FOR INTRAVENOUS USE. 

  • Rx Only

    Rev. 05/15

    CANTRELL DRUG COMPANY

    LITTLE ROCK, AR 72207

  • INGREDIENTS AND APPEARANCE
    HEPARIN SODIUM 
    heparin sodium injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52533-179
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Heparin Sodium (UNII: ZZ45AB24CA) (Heparin - UNII:T2410KM04A) Heparin100 [USP'U]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Chloride (UNII: 451W47IQ8X) 4.5 mg  in 1 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 0.0002 mL  in 1 mL
    Water (UNII: 059QF0KO0R)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containHYDROCHLORIC ACID (UNII: QTT17582CB)  
    May containSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52533-179-18250 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/15/2015
    Labeler - Cantrell Drug Company (035545763)
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