Amiodarone Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 829572556

Effective Date

May 7, 2025

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Amiodarone(50 mg in 1 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

70518-1231

Application Number

ANDA077234

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

May 7, 2025

Ingredients

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACTQuantity: 100 mg in 1 mL

BENZYL ALCOHOLInactive

Code: LKG8494WBHClass: IACTQuantity: 20.2 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

Code: 976728SY6ZClass: ACTIBQuantity: 50 mg in 1 mL