Dofetilide
Dofetilide Capsules Rx only
Approved
Approval ID
9bea7ddd-681c-4be5-8cf4-2e2df462745a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2023
Manufacturers
FDA
VGYAAN Pharmaceuticals LLC
DUNS: 024755855
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 Code72664-230
Application NumberANDA215323
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dofetilide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2023
FDA Product Classification
INGREDIENTS (14)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
DOFETILIDEActive
Quantity: 0.25 mg in 1 1
Code: R4Z9X1N2ND
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Dofetilide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72664-231
Application NumberANDA215323
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dofetilide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2023
FDA Product Classification
INGREDIENTS (14)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
DOFETILIDEActive
Quantity: 0.5 mg in 1 1
Code: R4Z9X1N2ND
Classification: ACTIB
Dofetilide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72664-229
Application NumberANDA215323
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dofetilide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2023
FDA Product Classification
INGREDIENTS (14)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
DOFETILIDEActive
Quantity: 0.125 mg in 1 1
Code: R4Z9X1N2ND
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT