Dofetilide
DOFETILIDE CAPSULES
Approved
Approval ID
66c20086-5030-441e-842d-2eee0d1a2a3a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 9, 2019
Manufacturers
FDA
Liberty Bioscience LLC
DUNS: 080399849
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dofetilide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71410-301
Application NumberANDA207058
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dofetilide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 17, 2018
FDA Product Classification
INGREDIENTS (16)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
Butyl AlcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
Isopropyl AlcoholInactive
Code: ND2M416302
Classification: IACT
AmmoniaInactive
Code: 5138Q19F1X
Classification: IACT
DOFETILIDEActive
Quantity: 0.25 mg in 1 1
Code: R4Z9X1N2ND
Classification: ACTIB
ShellacInactive
Code: 46N107B71O
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Dofetilide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71410-302
Application NumberANDA207058
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dofetilide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 17, 2018
FDA Product Classification
INGREDIENTS (16)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Isopropyl AlcoholInactive
Code: ND2M416302
Classification: IACT
AmmoniaInactive
Code: 5138Q19F1X
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
DOFETILIDEActive
Quantity: 0.5 mg in 1 1
Code: R4Z9X1N2ND
Classification: ACTIB
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
Butyl AlcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Dofetilide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71410-300
Application NumberANDA207058
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dofetilide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 17, 2018
FDA Product Classification
INGREDIENTS (16)
DOFETILIDEActive
Quantity: 0.125 mg in 1 1
Code: R4Z9X1N2ND
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
Isopropyl AlcoholInactive
Code: ND2M416302
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Butyl AlcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
AmmoniaInactive
Code: 5138Q19F1X
Classification: IACT