DESCOVY
These highlights do not include all the information needed to use DESCOVY safely and effectively. See full prescribing information for DESCOVY. DESCOVY (emtricitabine and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2015
Approved
Approval ID
06f66e98-e6ee-4538-9506-6c1282cc14c1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 13, 2022
Manufacturers
FDA
Gilead Sciences, Inc.
DUNS: 185049848
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
emtricitabine and tenofovir alafenamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61958-2002
Application NumberNDA208215
Product Classification
M
Marketing Category
C73594
G
Generic Name
emtricitabine and tenofovir alafenamide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2022
FDA Product Classification
INGREDIENTS (11)
EMTRICITABINEActive
Quantity: 200 mg in 1 1
Code: G70B4ETF4S
Classification: ACTIB
TENOFOVIR ALAFENAMIDE FUMARATEActive
Quantity: 25 mg in 1 1
Code: FWF6Q91TZO
Classification: ACTIR
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
emtricitabine and tenofovir alafenamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61958-2005
Application NumberNDA208215
Product Classification
M
Marketing Category
C73594
G
Generic Name
emtricitabine and tenofovir alafenamide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2022
FDA Product Classification
INGREDIENTS (10)
EMTRICITABINEActive
Quantity: 120 mg in 1 1
Code: G70B4ETF4S
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TENOFOVIR ALAFENAMIDE FUMARATEActive
Quantity: 15 mg in 1 1
Code: FWF6Q91TZO
Classification: ACTIR
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT