Label: AMIODARONE HCL - amiodarone hcl injection, solution

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

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Drug Label Information

Updated August 20, 2014

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  • INGREDIENTS AND APPEARANCE
    AMIODARONE HCL 
    amiodarone hcl injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52533-101
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (Amiodarone - UNII:N3RQ532IUT) AMIODARONE HYDROCHLORIDE 1.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Dextrose (UNII: IY9XDZ35W2) 50 mg  in 1 mL
    POLYSORBATE 80 (UNII: 6OZP39ZG8H) 3.6 mg  in 1 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) 0.73 mg  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52533-101-59 500 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/18/2013
    Labeler - Cantrell Drug Company (035545763)
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