Dofetilide
Dofetilide Capsules
Approved
Approval ID
b8323987-90fe-4e6c-a71c-76e3c501713c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 29, 2022
Manufacturers
FDA
Novadoz Pharmaceuticals LLC
DUNS: 081109687
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 Code72205-041
Application NumberANDA213220
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dofetilide
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2020
FDA Product Classification
INGREDIENTS (11)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DOFETILIDEActive
Quantity: 0.500 mg in 1 1
Code: R4Z9X1N2ND
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
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 Code72205-040
Application NumberANDA213220
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dofetilide
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2020
FDA Product Classification
INGREDIENTS (11)
DOFETILIDEActive
Quantity: 0.250 mg in 1 1
Code: R4Z9X1N2ND
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
Dofetilide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72205-039
Application NumberANDA213220
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dofetilide
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2020
FDA Product Classification
INGREDIENTS (13)
DOFETILIDEActive
Quantity: 0.125 mg in 1 1
Code: R4Z9X1N2ND
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT