Label: HEPARIN SODIUM injection, solution

  • 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 May 15, 2015

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

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!