Label: AMIODARONE HCL - amiodarone hydrochloride injection, solution 

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

Drug Label Information

Updated 08/14

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  • INGREDIENTS AND APPEARANCE
    AMIODARONE HCL 
    amiodarone hcl injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52533-101
    Route of Administration INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AMIODARONE HYDROCHLORIDE (Amiodarone) AMIODARONE HYDROCHLORIDE 1.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Dextrose 50 mg  in 1 mL
    POLYSORBATE 80 3.6 mg  in 1 mL
    BENZYL ALCOHOL 0.73 mg  in 1 mL
    WATER  
    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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