Propafenone Hydrochloride
These highlights do not include all the information needed to use PROPAFENONE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for PROPAFENONE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. PROPAFENONE HYDROCHLORIDE extended-release capsules, for oral useInitial U.S. Approval: 1989
Approved
Approval ID
bc1d2548-15a3-4986-92b1-c3ddfb35343a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 27, 2019
Manufacturers
FDA
Vitruvias Therapeutics
DUNS: 079200795
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
propafenone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69680-132
Application NumberANDA210339
Product Classification
M
Marketing Category
C73584
G
Generic Name
propafenone
Product Specifications
Route of AdministrationORAL
Effective DateJune 27, 2019
FDA Product Classification
INGREDIENTS (12)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROPAFENONE HYDROCHLORIDEActive
Quantity: 425 mg in 1 1
Code: 33XCH0HOCD
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
propafenone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69680-130
Application NumberANDA210339
Product Classification
M
Marketing Category
C73584
G
Generic Name
propafenone
Product Specifications
Route of AdministrationORAL
Effective DateJune 27, 2019
FDA Product Classification
INGREDIENTS (14)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
PROPAFENONE HYDROCHLORIDEActive
Quantity: 225 mg in 1 1
Code: 33XCH0HOCD
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
propafenone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69680-131
Application NumberANDA210339
Product Classification
M
Marketing Category
C73584
G
Generic Name
propafenone
Product Specifications
Route of AdministrationORAL
Effective DateJune 27, 2019
FDA Product Classification
INGREDIENTS (14)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPAFENONE HYDROCHLORIDEActive
Quantity: 325 mg in 1 1
Code: 33XCH0HOCD
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT