VEMLIDY

Product NDC: 61958-2301
11-digit product format: 619582301
Labeler code: 61958
Product ID: 61958-2301_175f5d1a-aae9-43d5-b004-65eefec167d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tenofovir alafenamide
Dosage form: TABLET
Route: ORAL
Labeler: Gilead Sciences, Inc.
Application: NDA208464
Marketing category: NDA
Marketing start: 2016-11-10
Substance: TENOFOVIR ALAFENAMIDE FUMARATE
Active strength: 25 mg/1
Pharmacologic classes: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208464-001	VEMLIDY	TENOFOVIR ALAFENAMIDE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N208464-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208464-001	8754065	2032-08-15	U-1275	Drug substance, Drug product	2016-11-28
N208464-001	8754065	2032-08-15	U-3880	Drug substance, Drug product	2016-11-28
N208464-001	8754065	2032-08-15	U-999	Drug substance, Drug product	2016-11-28
N208464-001	9296769	2032-08-15	U-1275	Drug substance, Drug product	2016-11-28
N208464-001	9296769	2032-08-15	U-3880	Drug substance, Drug product	2016-11-28
N208464-001	9296769	2032-08-15	U-999	Drug substance, Drug product	2016-11-28
N208464-001	8754065*PED	2033-02-15		Pediatric extension
N208464-001	9296769*PED	2033-02-15		Pediatric extension

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N208464-001	NPP	2027-03-27

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208464-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208464-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208464-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208464-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208464-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208464-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208464-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208464-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208464-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208464-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208464-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208464-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208464-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208464-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208464-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208464-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208464-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208464-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208464-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208464-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208464-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 314 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208464-001	8754065	2032-08-15	U-999	Drug substance, Drug product	2016-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208464-001	8754065	2032-08-15	U-1275	Drug substance, Drug product	2016-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208464-001	8754065	2032-08-15	U-3880	Drug substance, Drug product	2016-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208464-001	9296769	2032-08-15	U-1275	Drug substance, Drug product	2016-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208464-001	9296769	2032-08-15	U-3880	Drug substance, Drug product	2016-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208464-001	9296769	2032-08-15	U-999	Drug substance, Drug product	2016-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208464-001	8754065*PED	2033-02-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208464-001	9296769*PED	2033-02-15		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	7390791	2025-01-07		Drug substance, Drug product	2016-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	7390791*PED	2025-07-07		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	8754065	2032-08-15	U-999	Drug substance, Drug product	2016-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	8754065	2032-08-15	U-1275	Drug substance, Drug product	2016-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	8754065	2032-08-15	U-3880	Drug substance, Drug product	2016-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	9296769	2032-08-15	U-1275	Drug substance, Drug product	2016-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	9296769	2032-08-15	U-3880	Drug substance, Drug product	2016-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	9296769	2032-08-15	U-999	Drug substance, Drug product	2016-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	8754065*PED	2033-02-15		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	9296769*PED	2033-02-15		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208464-001	7390791	2025-01-07		Drug substance, Drug product	2016-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208464-001	7390791*PED	2025-07-07		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208464-001	8754065	2032-08-15	U-999	Drug substance, Drug product	2016-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208464-001	8754065	2032-08-15	U-1275	Drug substance, Drug product	2016-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208464-001	8754065	2032-08-15	U-3880	Drug substance, Drug product	2016-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208464-001	9296769	2032-08-15	U-1275	Drug substance, Drug product	2016-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208464-001	9296769	2032-08-15	U-3880	Drug substance, Drug product	2016-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208464-001	9296769	2032-08-15	U-999	Drug substance, Drug product	2016-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208464-001	8754065*PED	2033-02-15		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208464-001	9296769*PED	2033-02-15		Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	7390791	2025-01-07		Drug substance, Drug product	2016-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	7390791*PED	2025-07-07		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	8754065	2032-08-15	U-999	Drug substance, Drug product	2016-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	8754065	2032-08-15	U-1275	Drug substance, Drug product	2016-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	8754065	2032-08-15	U-3880	Drug substance, Drug product	2016-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	9296769	2032-08-15	U-1275	Drug substance, Drug product	2016-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	9296769	2032-08-15	U-3880	Drug substance, Drug product	2016-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	9296769	2032-08-15	U-999	Drug substance, Drug product	2016-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	8754065*PED	2033-02-15		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	9296769*PED	2033-02-15		Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208464-001	7390791	2025-01-07		Drug substance, Drug product	2016-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208464-001	7390791*PED	2025-07-07		Pediatric extension		`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 73 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	NPP	2025-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208464-001	NPP	2025-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	NPP	2025-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208464-001	NPP	2025-10-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208464-001	NPP	2025-10-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208464-001	NPP	2025-10-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208464-001	NPP	2025-10-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208464-001	NPP	2025-10-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208464-001	NPP	2025-10-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208464-001	NPP	2025-10-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208464-001	NPP	2025-10-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208464-001	NPP	2025-10-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208464-001	NPP	2025-10-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208464-001	M-255	2023-02-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208464-001	M-266	2023-08-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208464-001	M-255	2023-02-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208464-001	M-266	2023-08-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208464-001	M-255	2023-02-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208464-001	M-266	2023-08-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208464-001	NP	2019-11-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208464-001	NCE	2020-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208464-001	M-255	2023-02-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208464-001	M-266	2023-08-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208464-001	M-255	2023-02-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208464-001	M-266	2023-08-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208464-001	M-255	2023-02-04	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208464-001	M-266	2023-08-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208464-001	M-255	2023-02-04	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208464-001	M-266	2023-08-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208464-001	NCE	2020-11-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208464-001	M-255	2023-02-04	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208464-001	M-266	2023-08-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208464-001	NCE	2020-11-05	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208464-001	M-255	2023-02-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208464-001	NP	2019-11-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208464-001	NCE	2020-11-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208464-001	NP	2019-11-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208464-001	NCE	2020-11-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208464-001	NP	2019-11-11	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208464-001	NCE	2020-11-05	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: VEMLIDY
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TENOFOVIR ALAFENAMIDE FUMARATE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FWF6Q91TZO	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1858261	Internal RxNorm lookup
1858267	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
72e6b33c-0351-4070-9172-eeaa186c01d2	Available on FDA.report

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
c0c98dbe-5e23-74e9-f9fc-07af05f77d95	Product name	8	20240319
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
4ef90d80-1289-4267-a2bb-01c741d1208f	Product name	1	20230829
72dcca4e-6eae-4149-a92b-264c2a07004f	Product name	1	20230808
1cd1fd33-94db-4c45-bd26-82773ea350a3	Product name	2	20220317
14397d46-1c8c-bbf7-f4b7-5a7e59d3690f	Product name	4	20220314
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
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
8051c8a3-aee0-45a2-a236-8ee3f9e65f67	Product name	1	20181211
a56d673d-fa42-4b0e-b5ce-e65a5eab34b7	Product name	1	20180911
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d1784558-3c5f-4d73-8a7c-051102bb6c92	Product name	1	20160405
7fd46899-3505-4ed4-b856-6b2509a76004	Product name	1	20151123
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
0583b5e6-2e6e-c94b-9ff6-81a81ba199de	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61958-2301-1	VEMLIDY	30 in 1 BOTTLE, PLASTIC	TABLET	30		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61958-2301-1	EA - Each	61958-2301	919811d3-cde3-46d3-94f9-1e1ae9f2d299	1	2016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61958-2301	VEMLIDY (TENOFOVIR ALAFENAMIDE) TABLET [GILEAD SCIENCES, INC.]	16	Current NDC, Legacy NDC, 1 package rows	20240412_72e6b33c-0351-4070-9172-eeaa186c01d2.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
VEMLIDY	TENOFOVIR ALAFENAMIDE	Gilead Sciences, Inc.	72e6b33c-0351-4070-9172-eeaa186c01d2	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208464 application number: NDA208464 ndc (product): 61958-2301

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FWF6Q91TZO	TENOFOVIR ALAFENAMIDE FUMARATE	1392275-56-7	TENOFOVIR ALAFENAMIDE FUMARATE
EL9943AG5J	TENOFOVIR ALAFENAMIDE	379270-37-8	tenofovir alafenamide

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1858261	tenofovir alafenamide 25 MG Oral Tablet	PSN	72e6b33c-0351-4070-9172-eeaa186c01d2	17
1858267	Vemlidy 25 MG Oral Tablet	PSN	72e6b33c-0351-4070-9172-eeaa186c01d2	17
1858267	tenofovir alafenamide 25 MG Oral Tablet [Vemlidy]	SBD	72e6b33c-0351-4070-9172-eeaa186c01d2	17
1858261	tenofovir alafenamide 25 MG Oral Tablet	SCD	72e6b33c-0351-4070-9172-eeaa186c01d2	17
1858261	tenofovir alafenamide 25 MG (equiv. to 28 MG tenofovir alafenamide fumarate) Oral Tablet	SY	72e6b33c-0351-4070-9172-eeaa186c01d2	17
1858267	Vemlidy 25 MG (equiv. to 28 MG tenofovir alafenamide fumarate) Oral Tablet	SY	72e6b33c-0351-4070-9172-eeaa186c01d2	17
1858267	Vemlidy 25 MG Oral Tablet	SY	72e6b33c-0351-4070-9172-eeaa186c01d2	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61958-2301-1	61958230101	30 TABLET in 1 BOTTLE, PLASTIC (61958-2301-1)	30 tablet	2016-11-10	0000-00-00	No	No	Current