Propafenone Hydrochloride
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for PROPAFENONE HYDROCHLORIDE TABLETS. PROPAFENONE HYDROCHLORIDE tablets, for oral useInitial U.S. Approval: 1989
Approved
Approval ID
41b4e503-60a6-4662-a6f9-46ecf93d930a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2024
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Propafenone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-4227
Application NumberANDA076550
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propafenone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2015
FDA Product Classification
INGREDIENTS (13)
PROPAFENONE HYDROCHLORIDEActive
Quantity: 225 mg in 1 1
Code: 33XCH0HOCD
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT