Label: NOREPINEPHRINE BITARTRATE injection, solution

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

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Drug Label Information

Updated March 6, 2015

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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

    Norepinephrine bitartrate injection solution is supplied as a sterile, nonpyrogenic solution that is clear, colorless at 250 mL in a Single-Dose Injection Solution Bag.


    This product is Preservative-Free and Latex-Free.

  • • INGREDIENTS

    Each 1 mL contains the equivalent of 16 mcg norepinephrine base, 50 mg dextrose, 118.4 mcg sodium chloride, 32 mcg sodium metabisulfite, and pH adjusters include hydrochloric acid and/or sodium hydroxide, if necessary.

  • • STORAGE AND HANDLING

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


    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit.


    Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate.

  • • DOSAGE AND ADMINISTRATION.

    FOR INTRAVENOUS USE ONLY. PRESERVATIVE-FREE INJECTION SOLUTION.

  • SPL UNCLASSIFIED SECTION

    Rx Only

    Rev. 03/15

    CANTRELL DRUG COMPANY
    LITTLE ROCK, AR 72207

  • INGREDIENTS AND APPEARANCE
    NOREPINEPHRINE BITARTRATE 
    norepinephrine bitartrate injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52533-165
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Norepinephrine Bitartrate (UNII: IFY5PE3ZRW) (Norepinephrine - UNII:X4W3ENH1CV) Norepinephrine16 ug  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) 50 mg  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 118.4 ug  in 1 mL
    SODIUM METABISULFITE (UNII: 4VON5FNS3C) 32 ug  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:52533-165-18250 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/06/2015
    Labeler - Cantrell Drug Company (035545763)
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