Amiodarone hcl injection, solution

Spl unclassified section

Ingredients and appearance - Product information

Amiodarone hcl injection, solution- Amiodarone hcl

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 52533-101
Route of Administration Intravenous

Active Ingredient/Active Moiety

Ingredient Name Strength
Amiodarone hydrochloride ( UNII: 976728SY6Z)( Amiodarone - UNII: N3RQ532IUT ) 1.8 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Dextrose ( UNII: IY9XDZ35W2)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Benzyl alcohol ( UNII: LKG8494WBH)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved drug other USA

Labeler - Cantrell Drug Company( 035545763)

Package label.principal display panel