Biktarvy
These highlights do not include all the information needed to use BIKTARVY safely and effectively. See full prescribing information for BIKTARVY. BIKTARVY (bictegravir, emtricitabine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2018
Approved
Approval ID
0476d7eb-1024-4821-bbe7-abaacfda32a2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-6247
Application NumberNDA210251
Product Classification
M
Marketing Category
C73594
G
Generic Name
bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 21, 2022
FDA Product Classification
INGREDIENTS (13)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TENOFOVIR ALAFENAMIDE FUMARATEActive
Quantity: 25 mg in 1 1
Code: FWF6Q91TZO
Classification: ACTIR
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
BICTEGRAVIR SODIUMActive
Quantity: 50 mg in 1 1
Code: 4L5MP1Y7W7
Classification: ACTIM
EMTRICITABINEActive
Quantity: 200 mg in 1 1
Code: G70B4ETF4S
Classification: ACTIB
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT