Epclusa Access
These highlights do not include all the information needed to use EPCLUSA safely and effectively. See full prescribing information for EPCLUSA. EPCLUSA™ (sofosbuvir and velpatasvir) tablets, for oral use Initial U.S. Approval: 2016 GILEAD ACCESS PROGRAM
Approved
Approval ID
996466df-f236-4804-b10f-838aa83231a1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2020
Manufacturers
FDA
Gilead Sciences, Inc.
DUNS: 185049848
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Velpatasvir and Sofosbuvir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61958-2202
Product Classification
G
Generic Name
Velpatasvir and Sofosbuvir
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2020
FDA Product Classification
INGREDIENTS (14)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
VELPATASVIRActive
Quantity: 100 mg in 1 1
Code: KCU0C7RS7Z
Classification: ACTIB
SOFOSBUVIRActive
Quantity: 400 mg in 1 1
Code: WJ6CA3ZU8B
Classification: ACTIB