Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Epclusa
Product Details
NDC Product Code
61958-2201Application Number
NDA208341Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
April 30, 2022VelpatasvirActive
Code: KCU0C7RS7ZClass: ACTIBQuantity: 100 mg in 1 1
SofosbuvirActive
Code: WJ6CA3ZU8BClass: ACTIBQuantity: 400 mg in 1 1
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
Epclusa
Product Details
NDC Product Code
61958-2204Application Number
NDA214187Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
April 30, 2022VelpatasvirActive
Code: KCU0C7RS7ZClass: ACTIBQuantity: 50 mg in 1 1
SofosbuvirActive
Code: WJ6CA3ZU8BClass: ACTIBQuantity: 200 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIHClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TARTARIC ACIDInactive
Code: W4888I119HClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Epclusa
Product Details
NDC Product Code
61958-2205Application Number
NDA214187Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
April 30, 2022VelpatasvirActive
Code: KCU0C7RS7ZClass: ACTIBQuantity: 37.5 mg in 1 1
SofosbuvirActive
Code: WJ6CA3ZU8BClass: ACTIBQuantity: 150 mg in 1 1
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TARTARIC ACIDInactive
Code: W4888I119HClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIHClass: IACT
Epclusa
Product Details
NDC Product Code
61958-2203Application Number
NDA208341Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
April 30, 2022POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
VelpatasvirActive
Code: KCU0C7RS7ZClass: ACTIBQuantity: 50 mg in 1 1
COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SofosbuvirActive
Code: WJ6CA3ZU8BClass: ACTIBQuantity: 200 mg in 1 1
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT