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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61958-1802
Product Classification
G
Generic Name
LEDIPASVIR and SOFOSBUVIR
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2020
FDA Product Classification
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