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
2ecd6452-ccc3-493f-9a4a-69f0fbf67a42
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 7, 2021
Manufacturers
FDA
Northstar Rx LLC
DUNS: 830546433
Products 3
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 Code16714-826
Application NumberANDA205268
Product Classification
M
Marketing Category
C73584
G
Generic Name
propafenone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 7, 2021
FDA Product Classification
INGREDIENTS (11)
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
PROPAFENONE HYDROCHLORIDEActive
Quantity: 325 mg in 1 1
Code: 33XCH0HOCD
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
propafenone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-825
Application NumberANDA205268
Product Classification
M
Marketing Category
C73584
G
Generic Name
propafenone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 7, 2021
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPAFENONE HYDROCHLORIDEActive
Quantity: 225 mg in 1 1
Code: 33XCH0HOCD
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
propafenone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-827
Application NumberANDA205268
Product Classification
M
Marketing Category
C73584
G
Generic Name
propafenone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 7, 2021
FDA Product Classification
INGREDIENTS (11)
PROPAFENONE HYDROCHLORIDEActive
Quantity: 425 mg in 1 1
Code: 33XCH0HOCD
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT