Harvoni Access
These highlights do not include all the information needed to use HARVONI™ safely and effectively. See full prescribing information for HARVONI. HARVONI (ledipasvir and sofosbuvir) tablets, for oral use GILEAD ACCESS PROGRAM Initial U.S. Approval: 2014
Approved
Approval ID
1a1c555d-2fdf-4150-8ace-dbc770c226bf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 25, 2021
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.
LEDIPASVIR and SOFOSBUVIR
PRODUCT DETAILS
NDC Product Code61958-1802
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateDecember 14, 2020
Generic NameLEDIPASVIR and SOFOSBUVIR
INGREDIENTS (14)
SOFOSBUVIRActive
Quantity: 400 mg in 1 1
Code: WJ6CA3ZU8B
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LEDIPASVIRActive
Quantity: 90 mg in 1 1
Code: 013TE6E4WV
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT