Biktarvy

Product NDC: 61958-2501
11-digit product format: 619582501
Labeler code: 61958
Product ID: 61958-2501_261dcc2a-c849-46b1-abf6-4981ed2c60bc
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: 2018-02-07
Substance: BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Active strength: 50; 200; 25 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N210251-001	BIKTARVY	BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2018-02-07
N210251-002	BIKTARVY	BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL		RLD	2021-10-07

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210251-001	8754065	2032-08-15	U-257	Drug substance, Drug product	2018-02-26
N210251-001	9296769	2032-08-15	U-257	Drug substance, Drug product	2018-02-26
N210251-001	8754065*PED	2033-02-15		Pediatric extension
N210251-001	9296769*PED	2033-02-15		Pediatric extension
N210251-001	9216996	2033-12-19		Drug substance, Drug product	2018-02-26
N210251-001	9732092	2033-12-19		Drug substance, Drug product	2018-02-26
N210251-001	10385067	2035-06-19	U-257		2019-08-30
N210251-001	9708342	2035-06-19		Drug substance, Drug product	2018-02-26
N210251-001	10548846	2036-11-08		Drug product	2020-02-28
N210251-001	11744802	2036-11-08		Drug product	2023-10-04
N210251-001	12594244	2036-11-08	U-257	Drug product	2026-04-30
N210251-002	8754065	2032-08-15	U-257	Drug substance, Drug product	2021-10-28
N210251-002	9296769	2032-08-15	U-257	Drug substance, Drug product	2021-10-28
N210251-002	8754065*PED	2033-02-15		Pediatric extension
N210251-002	9296769*PED	2033-02-15		Pediatric extension
N210251-002	9216996	2033-12-19		Drug substance, Drug product	2021-10-28
N210251-002	9732092	2033-12-19		Drug substance, Drug product	2021-10-28
N210251-002	10385067	2035-06-19	U-257		2021-10-28
N210251-002	9708342	2035-06-19		Drug substance, Drug product	2021-10-28
N210251-002	12594244	2036-11-08	U-257	Drug product	2026-04-30

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 9 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N210251-001	ODE-256	2026-06-18
N210251-001	I-942	2027-02-23
N210251-001	M-305	2027-04-24
N210251-001	ODE-468	2031-02-23
N210251-001	ODE-540	2032-07-30
N210251-002	I-942	2027-02-23
N210251-002	ODE-378	2028-10-07
N210251-002	ODE-468	2031-02-23
N210251-002	ODE-540	2032-07-30

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`4b0b4de00fa7…`

Observed Orange Book patent history#

Patent history page 1 of 21 · 815 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N210251-001	8754065	2032-08-15	U-257	Drug substance, Drug product	2018-02-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-001	9296769	2032-08-15	U-257	Drug substance, Drug product	2018-02-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-001	8754065*PED	2033-02-15		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-001	9296769*PED	2033-02-15		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-001	9216996	2033-12-19		Drug substance, Drug product	2018-02-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-001	9732092	2033-12-19		Drug substance, Drug product	2018-02-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-001	10385067	2035-06-19	U-257		2019-08-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-001	9708342	2035-06-19		Drug substance, Drug product	2018-02-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-001	10548846	2036-11-08		Drug product	2020-02-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-001	11744802	2036-11-08		Drug product	2023-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-001	12594244	2036-11-08	U-257	Drug product	2026-04-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-002	8754065	2032-08-15	U-257	Drug substance, Drug product	2021-10-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-002	9296769	2032-08-15	U-257	Drug substance, Drug product	2021-10-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-002	8754065*PED	2033-02-15		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-002	9296769*PED	2033-02-15		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-002	9216996	2033-12-19		Drug substance, Drug product	2021-10-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-002	9732092	2033-12-19		Drug substance, Drug product	2021-10-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-002	10385067	2035-06-19	U-257		2021-10-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-002	9708342	2035-06-19		Drug substance, Drug product	2021-10-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-002	12594244	2036-11-08	U-257	Drug product	2026-04-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N210251-001	8754065	2032-08-15	U-257	Drug substance, Drug product	2018-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-001	9296769	2032-08-15	U-257	Drug substance, Drug product	2018-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-001	8754065*PED	2033-02-15		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-001	9296769*PED	2033-02-15		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-001	9216996	2033-12-19		Drug substance, Drug product	2018-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-001	9732092	2033-12-19		Drug substance, Drug product	2018-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-001	10385067	2035-06-19	U-257		2019-08-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-001	9708342	2035-06-19		Drug substance, Drug product	2018-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-001	10548846	2036-11-08		Drug product	2020-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-001	11744802	2036-11-08		Drug product	2023-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-001	12594244	2036-11-08	U-257	Drug product	2026-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-002	8754065	2032-08-15	U-257	Drug substance, Drug product	2021-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-002	9296769	2032-08-15	U-257	Drug substance, Drug product	2021-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-002	8754065*PED	2033-02-15		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-002	9296769*PED	2033-02-15		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-002	9216996	2033-12-19		Drug substance, Drug product	2021-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-002	9732092	2033-12-19		Drug substance, Drug product	2021-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-002	10385067	2035-06-19	U-257		2021-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-002	9708342	2035-06-19		Drug substance, Drug product	2021-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-002	12594244	2036-11-08	U-257	Drug product	2026-04-30	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 7 · 260 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N210251-001	ODE-256	2026-06-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-001	I-942	2027-02-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-001	M-305	2027-04-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-001	ODE-468	2031-02-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-001	ODE-540	2032-07-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-002	I-942	2027-02-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-002	ODE-378	2028-10-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-002	ODE-468	2031-02-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210251-002	ODE-540	2032-07-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N210251-001	ODE-256	2026-06-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-001	I-942	2027-02-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-001	M-305	2027-04-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-001	ODE-468	2031-02-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-001	ODE-540	2032-07-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-002	I-942	2027-02-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-002	ODE-378	2028-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-002	ODE-468	2031-02-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210251-002	ODE-540	2032-07-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210251-001	ODE-256	2026-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210251-001	I-942	2027-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210251-001	M-305	2027-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210251-001	ODE-468	2031-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210251-001	ODE-540	2032-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210251-002	I-942	2027-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210251-002	ODE-378	2028-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210251-002	ODE-468	2031-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210251-002	ODE-540	2032-07-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210251-001	ODE-256	2026-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-001	I-942	2027-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-001	M-305	2027-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-001	ODE-468	2031-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-002	I-942	2027-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-002	ODE-378	2028-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-002	ODE-468	2031-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-001	ODE-256	2026-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-001	I-942	2027-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-001	M-305	2027-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-001	ODE-468	2031-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-002	I-942	2027-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-002	ODE-378	2028-10-07	`31067a03dcf5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Biktarvy
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BICTEGRAVIR SODIUM	50 mg/1
EMTRICITABINE	200 mg/1
TENOFOVIR ALAFENAMIDE FUMARATE	25 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
33cd1557-9629-1a35-1f2f-499cf7c608bc	Product name	2	20260305
5f93de8c-a439-4aaa-862f-7cf2524cb240	Product name	3	20250812
6286e356-28a5-4b4b-a174-76bf53b211e3	Product name	6	20250121
233e3f87-da6c-4b7d-80cb-963ca3258270	Product name	2	20240419
dc21b1c2-b0f7-7f56-b95f-dcd93cbc30a4	Product name	3	20240320
c0c98dbe-5e23-74e9-f9fc-07af05f77d95	Product name	8	20240319
4ef90d80-1289-4267-a2bb-01c741d1208f	Product name	1	20230829
72dcca4e-6eae-4149-a92b-264c2a07004f	Product name	1	20230808
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
1cd1fd33-94db-4c45-bd26-82773ea350a3	Product name	2	20220317
14397d46-1c8c-bbf7-f4b7-5a7e59d3690f	Product name	4	20220314
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
320f244d-8b4e-4893-9f14-104b2a8e0aaf	Product name	2	20201007
7ff71f22-5b66-4a3d-bf64-671893a6409d	Product name	2	20201007
6f122144-2ceb-48fa-a906-0d2eb742717e	Product name	1	20190624
8051c8a3-aee0-45a2-a236-8ee3f9e65f67	Product name	1	20181211
a56d673d-fa42-4b0e-b5ce-e65a5eab34b7	Product name	1	20180911
d1784558-3c5f-4d73-8a7c-051102bb6c92	Product name	1	20160405
7fd46899-3505-4ed4-b856-6b2509a76004	Product name	1	20151123
0583b5e6-2e6e-c94b-9ff6-81a81ba199de	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
61958-2501-1	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
61958-2501-1	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
61958-2501-1	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
61958-2501-1	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
61958-2501-1	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
61958-2501-2	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
61958-2501-2	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
61958-2501-2	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
61958-2501-2	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
61958-2501-2	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61958-2501-1	Biktarvy	30 in 1 BOTTLE, PLASTIC	TABLET	30	24
61958-2501-2	Biktarvy	7 in 1 BOTTLE, PLASTIC	TABLET	7	24
61958-2501-3	Biktarvy	30 in 1 BLISTER PACK	TABLET	30	24
61958-2501-5	Biktarvy	30 in 1 BLISTER PACK	TABLET	30	24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61958-2501-1	EA - Each	61958-2501	6aa39ee3-3afc-4ca2-b2e0-a3fdd44e9b22	1	2018-03-08
61958-2501-3	EA - Each	61958-2501	3e8532ff-f9f4-48b0-b2b2-8bb1eece913a	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61958-2501	BIKTARVY (BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]	20	Current NDC, Legacy NDC, 4 package rows	20241024_664cb8f0-1f65-441b-b0d9-ba3d798be309.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Biktarvy	BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE	A-S Medication Solutions	0476d7eb-1024-4821-bbe7-abaacfda32a2	2024-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 210251 application number: NDA210251

UNII, Preferred term, Registry number table
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2584354	bictegravir 30 MG / emtricitabine 120 MG / tenofovir alafenamide 15 MG Oral Tablet	PSN	664cb8f0-1f65-441b-b0d9-ba3d798be309	24
1999667	bictegravir 50 MG / emtricitabine 200 MG / tenofovir alafenamide 25 MG Oral Tablet	PSN	664cb8f0-1f65-441b-b0d9-ba3d798be309	24
2584356	Biktarvy 30 MG / 120 MG / 15 MG Oral Tablet	PSN	664cb8f0-1f65-441b-b0d9-ba3d798be309	24
1999673	Biktarvy 50 MG / 200 MG / 25 MG Oral Tablet	PSN	664cb8f0-1f65-441b-b0d9-ba3d798be309	24
2584356	bictegravir 30 MG / emtricitabine 120 MG / tenofovir alafenamide 15 MG Oral Tablet [Biktarvy]	SBD	664cb8f0-1f65-441b-b0d9-ba3d798be309	24
1999673	bictegravir 50 MG / emtricitabine 200 MG / tenofovir alafenamide 25 MG Oral Tablet [Biktarvy]	SBD	664cb8f0-1f65-441b-b0d9-ba3d798be309	24
2584354	bictegravir 30 MG / emtricitabine 120 MG / tenofovir alafenamide 15 MG Oral Tablet	SCD	664cb8f0-1f65-441b-b0d9-ba3d798be309	24
1999667	bictegravir 50 MG / emtricitabine 200 MG / tenofovir alafenamide 25 MG Oral Tablet	SCD	664cb8f0-1f65-441b-b0d9-ba3d798be309	24
2584354	bictegravir 30 MG (as bictegravir sodium 31.5 MG) / emtricitabine 120 MG / tenofovir alafenamide 15 MG (as tenofovir alafenamide fumarate 16.5 MG) Oral Tablet	SY	664cb8f0-1f65-441b-b0d9-ba3d798be309	24
1999667	bictegravir 50 MG (as bictegravir sodium 52.5 MG) / emtricitabine 200 MG / tenofovir alafenamide 25 MG (as tenofovir alafenamide fumarate 28 MG) Oral Tablet	SY	664cb8f0-1f65-441b-b0d9-ba3d798be309	24
2584356	Biktarvy 30 MG / 120 MG / 15 MG Oral Tablet	SY	664cb8f0-1f65-441b-b0d9-ba3d798be309	24
1999673	Biktarvy 50 MG / 200 MG / 25 MG Oral Tablet	SY	664cb8f0-1f65-441b-b0d9-ba3d798be309	24
1999667	bictegravir 50 MG / emtricitabine 200 MG / tenofovir alafenamide 25 MG Oral Tablet	PSN	0476d7eb-1024-4821-bbe7-abaacfda32a2	5
1999673	Biktarvy 50 MG / 200 MG / 25 MG Oral Tablet	PSN	0476d7eb-1024-4821-bbe7-abaacfda32a2	5
1999673	bictegravir 50 MG / emtricitabine 200 MG / tenofovir alafenamide 25 MG Oral Tablet [Biktarvy]	SBD	0476d7eb-1024-4821-bbe7-abaacfda32a2	5
1999667	bictegravir 50 MG / emtricitabine 200 MG / tenofovir alafenamide 25 MG Oral Tablet	SCD	0476d7eb-1024-4821-bbe7-abaacfda32a2	5
1999667	bictegravir 50 MG (as bictegravir sodium 52.5 MG) / emtricitabine 200 MG / tenofovir alafenamide 25 MG (as tenofovir alafenamide fumarate 28 MG) Oral Tablet	SY	0476d7eb-1024-4821-bbe7-abaacfda32a2	5
1999673	Biktarvy 50 MG / 200 MG / 25 MG Oral Tablet	SY	0476d7eb-1024-4821-bbe7-abaacfda32a2	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61958-2501-1	61958250101	30 TABLET in 1 BOTTLE, PLASTIC (61958-2501-1)	30 tablet	2018-02-07	0000-00-00	No	No	Current
61958-2501-2	61958250102	7 TABLET in 1 BOTTLE, PLASTIC (61958-2501-2)	7 tablet	2018-07-26	0000-00-00	No	No	Current
61958-2501-3	61958250103	30 TABLET in 1 BLISTER PACK (61958-2501-3)	30 tablet	2021-08-24	0000-00-00	No	No	Current
61958-2501-5	61958250105	30 TABLET in 1 BLISTER PACK (61958-2501-5)	30 tablet	2026-03-30		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Biktarvy	Gilead Sciences, Inc.	2026-09-09	HUMAN PRESCRIPTION DRUG LABEL	26
Biktarvy	REMEDYREPACK INC.	2025-01-15	HUMAN PRESCRIPTION DRUG LABEL	5
Biktarvy	A-S Medication Solutions	2024-04-30	HUMAN PRESCRIPTION DRUG LABEL	5