Sovaldi
These highlights do not include all the information needed to use SOVALDI safely and effectively. See full prescribing information for SOVALDI. SOVALDI (sofosbuvir) tablets, for oral use SOVALDI (sofosbuvir) oral pellets Initial U.S. Approval: 2013
Approved
Approval ID
80beab2c-396e-4a37-a4dc-40fdb62859cf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2023
Manufacturers
FDA
Gilead Sciences, Inc.
DUNS: 185049848
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SOFOSBUVIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61958-1501
Application NumberNDA204671
Product Classification
M
Marketing Category
C73594
G
Generic Name
SOFOSBUVIR
Product Specifications
Route of AdministrationORAL
Effective DateMarch 12, 2020
FDA Product Classification
INGREDIENTS (12)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SOFOSBUVIRActive
Quantity: 400 mg in 1 1
Code: WJ6CA3ZU8B
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SOFOSBUVIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61958-1503
Application NumberNDA204671
Product Classification
M
Marketing Category
C73594
G
Generic Name
SOFOSBUVIR
Product Specifications
Route of AdministrationORAL
Effective DateMarch 12, 2020
FDA Product Classification
INGREDIENTS (12)
SOFOSBUVIRActive
Quantity: 200 mg in 1 1
Code: WJ6CA3ZU8B
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SOFOSBUVIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61958-1504
Application NumberNDA212480
Product Classification
M
Marketing Category
C73594
G
Generic Name
SOFOSBUVIR
Product Specifications
Route of AdministrationORAL
Effective DateMarch 12, 2020
FDA Product Classification
INGREDIENTS (14)
SOFOSBUVIRActive
Quantity: 150 mg in 1 1
Code: WJ6CA3ZU8B
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SOFOSBUVIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61958-1505
Application NumberNDA212480
Product Classification
M
Marketing Category
C73594
G
Generic Name
SOFOSBUVIR
Product Specifications
Route of AdministrationORAL
Effective DateMarch 12, 2020
FDA Product Classification
INGREDIENTS (14)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SOFOSBUVIRActive
Quantity: 200 mg in 1 1
Code: WJ6CA3ZU8B
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT