Propafenone HCl
These highlights do not include all the information needed to use PROPAFENONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PROPAFENONE HYDROCHLORIDE TABLETS . PROPAFENONE HYDROCHLORIDE t ablets , for oral use Initial U.S. Approval: 1989
Approved
Approval ID
a313c111-e539-47bc-9d57-c3767f74bcca
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 28, 2019
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
Products 2
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 Code0591-0582
Application NumberANDA075203
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propafenone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2019
FDA Product Classification
INGREDIENTS (13)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PROPAFENONE HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: 33XCH0HOCD
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Propafenone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0591-0583
Application NumberANDA075203
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propafenone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2019
FDA Product Classification
INGREDIENTS (13)
PROPAFENONE HYDROCHLORIDEActive
Quantity: 225 mg in 1 1
Code: 33XCH0HOCD
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT