Label: AMIODARONE HCL injection, solution
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Contains inactivated NDC Code(s)
NDC Code(s): 52533-101-59 - Packager: Cantrell Drug Company
- 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, solutionProduct 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)
