Biktarvy

Product NDC: 61958-2506
11-digit product format: 619582506
Labeler code: 61958
Product ID: 61958-2506_245103e5-132e-4695-9b7d-bda2f2830ec3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate
Dosage form: TABLET
Route: ORAL
Labeler: Gilead Sciences, Inc.
Application: NDA210251
Marketing category: NDA
Marketing start: 2024-10-08
Substance: BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Active strength: 30; 120; 15 mg/1; mg/1; mg/1
Pharmacologic classes: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data

Ingredient	Strength
BICTEGRAVIR SODIUM	30 mg/1
EMTRICITABINE	120 mg/1
TENOFOVIR ALAFENAMIDE FUMARATE	15 mg/1

Field	Values
Unii	FWF6Q91TZO, 4L5MP1Y7W7, G70B4ETF4S
Rxcui	1999667, 1999673, 2584354, 2584356

UNII	Preferred term	Registry number	Matched term
4L5MP1Y7W7	BICTEGRAVIR SODIUM	1807988-02-8	BICTEGRAVIR SODIUM
G70B4ETF4S	EMTRICITABINE	143491-57-0	EMTRICITABINE
FWF6Q91TZO	TENOFOVIR ALAFENAMIDE FUMARATE	1392275-56-7	TENOFOVIR ALAFENAMIDE FUMARATE

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
61958-2506-1	61958250601	30 TABLET in 1 BOTTLE, PLASTIC (61958-2506-1)	30 tablet	2024-10-08	No	No	Current

Title	Manufacturer	Effective date	Type	Version
Biktarvy	Gilead Sciences, Inc.	2026-03-30	HUMAN PRESCRIPTION DRUG LABEL	24