Label: HYDROMORPHONE HCL - hydromorphone hcl injection, solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CII
  • 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 March 30, 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 100 mL (100 mg) of Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride in a 100 mL Single-Dose Bag that is a 50 mL Prefilled Bag with 100 mL Total Volume.

    This product is Sterile, Nonpyrogenic, Preservative Free, Isotonic, and Latex Free.

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  • • INGREDIENTS

    Each 1 mL contains Hydromorphone HCl 1 mg, Sodium Chloride 9 mg. 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]. Protect from freezing. Protect from Light.

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  • • DOSAGE AND ADMINISTRATION.

    FOR SLOW INTRAVENOUS USE. PRESERVATIVE FREE INJECTION SOLUTION.

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  • Rx Only

    Rev. 03/15

    CANTRELL DRUG COMPANY

    LITTLE ROCK, AR 72207

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  • INGREDIENTS AND APPEARANCE
    HYDROMORPHONE HCL 
    hydromorphone hcl injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52533-006
    Route of Administration INTRAVENOUS DEA Schedule CII    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROMORPHONE HYDROCHLORIDE (UNII: L960UP2KRW) (HYDROMORPHONE - UNII:Q812464R06) HYDROMORPHONE HYDROCHLORIDE 1 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Sodium Chloride (UNII: 451W47IQ8X) 9 mg  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:52533-006-75 100 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 04/01/2015
    Labeler - Cantrell Drug Company (035545763)
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