Propafenone Hydrochloride
PROPAFENONE HYDROCHLORIDE TABLETS
Approved
Approval ID
a7c8f090-c48c-44f7-9973-2cf4b491e35c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2013
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-4770
Application NumberANDA075998
Product Classification
M
Marketing Category
C73584
G
Generic Name
propafenone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2013
FDA Product Classification
INGREDIENTS (13)
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
PROPAFENONE HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: 33XCH0HOCD
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
propafenone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5950
Application NumberANDA075998
Product Classification
M
Marketing Category
C73584
G
Generic Name
propafenone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2013
FDA Product Classification
INGREDIENTS (13)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPAFENONE HYDROCHLORIDEActive
Quantity: 225 mg in 1 1
Code: 33XCH0HOCD
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT