Amiodarone Hydrochloride
These highlights do not include all the information needed to use Amiodarone Hydrochloride Injection, USP safely and effectively. See full prescribing information for Amiodarone Hydrochloride Injection, USP. AMIODARONE Hydrochloride Injection, USP for intravenous use Initial U.S. Approval: 1995
Approved
Approval ID
e9151c1b-b70c-477b-868a-fffdc5c51830
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
REMEDYREPACK INC.
DUNS: 829572556
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amiodarone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70518-1231
Application NumberANDA077234
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amiodarone Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (4)
POLYSORBATE 80Inactive
Quantity: 100 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 20.2 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
AMIODARONE HYDROCHLORIDEActive
Quantity: 50 mg in 1 mL
Code: 976728SY6Z
Classification: ACTIB