Label: HEPARIN SODIUM - heparin sodium injection, solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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 May 15, 2015

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  • • WARNINGS AND PRECAUTIONS

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

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  • • ADVERSE EVENTS

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

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  • • 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.

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  • • 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.

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  • • STORAGE AND HANDLING

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

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  • • DOSAGE AND ADMINISTRATION.

    FOR INTRAVENOUS USE. 

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  • Rx Only

    Rev. 05/15

    CANTRELL DRUG COMPANY

    LITTLE ROCK, AR 72207

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  • INGREDIENTS AND APPEARANCE
    HEPARIN SODIUM 
    heparin sodium injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52533-179
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Heparin Sodium (UNII: ZZ45AB24CA) (Heparin - UNII:T2410KM04A) Heparin 100 [USP'U]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Kind Ingredient Name Quantity
    May contain HYDROCHLORIC ACID (UNII: QTT17582CB)  
    May contain SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52533-179-18 250 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 other 05/15/2015
    Labeler - Cantrell Drug Company (035545763)
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