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
f3e631c5-1204-419c-8dbe-fa9b37a77f97
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2021
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code71335-0881
Application NumberANDA075424
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amiodarone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2020
FDA Product Classification
INGREDIENTS (9)
AMIODARONE HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: 976728SY6Z
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT