Amiodarone Hydrochloride
These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
Approved
Approval ID
d912a75a-ddac-4e7b-b5c4-321d4252ec05
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 19, 2023
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
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 Code60687-437
Application NumberANDA204742
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amiodarone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 19, 2023
FDA Product Classification
INGREDIENTS (6)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
AMIODARONE HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: 976728SY6Z
Classification: ACTIB