DESCOVY

Product NDC: 70518-0230
11-digit product format: 705180230
Labeler code: 70518
Product ID: 70518-0230_d332b82f-b08c-0350-e053-2995a90aa55a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: emtricitabine and tenofovir alafenamide fumarate
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: NDA208215
Marketing category: NDA
Marketing start: 2017-02-16
Marketing end: 0000-00-00
Substance: EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Active strength: 200 mg/1; mg/1
Pharmacologic classes: Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70518-0230		D	Discontinued by firm		2026-08-17
excluded package	package	70518-0230	70518-0230-0	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-0230-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-0230-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-0230-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-0230-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-0230-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N208215-001	DESCOVY	EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-04-04
N208215-002	DESCOVY	EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	120MG;EQ 15MG BASE	TABLET / ORAL		RLD	2022-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N208215-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208215-001	8754065	2032-08-15	U-1259	Drug substance, Drug product	2016-05-02
N208215-001	8754065	2032-08-15	U-1663	Drug substance, Drug product	2016-05-02
N208215-001	8754065	2032-08-15	U-257	Drug substance, Drug product	2016-05-02
N208215-001	9296769	2032-08-15	U-1259	Drug substance, Drug product	2016-04-26
N208215-001	9296769	2032-08-15	U-1663	Drug substance, Drug product	2016-04-26
N208215-001	9296769	2032-08-15	U-257	Drug substance, Drug product	2016-04-26
N208215-001	8754065*PED	2033-02-15		Pediatric extension
N208215-001	9296769*PED	2033-02-15		Pediatric extension
N208215-001	12629338	2036-06-29		Drug product	2026-05-19
N208215-001	12648911	2036-06-29	U-1259		2026-06-09
N208215-001	12648911	2036-06-29	U-1663		2026-06-09
N208215-001	12661323	2036-06-29		Drug product	2026-06-23
N208215-001	12678408	2036-06-29		Drug product	2026-07-15
N208215-002	8754065	2032-08-15	U-1663	Drug substance, Drug product	2022-02-04
N208215-002	9296769	2032-08-15	U-1663	Drug substance, Drug product	2022-02-04
N208215-002	8754065*PED	2033-02-15		Pediatric extension
N208215-002	9296769*PED	2033-02-15		Pediatric extension
N208215-002	12661323	2036-06-29		Drug product	2026-06-23

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 5 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N208215-001	M-316	2028-06-20
N208215-001	ODE-556	2032-06-20
N208215-002	M-316	2028-06-20
N208215-002	ODE-554	2029-01-07
N208215-002	ODE-556	2032-06-20

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 · 75 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
2026-08-18 06:07:40	2026-07	N208215-001	DESCOVY	200MG;EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208215-002	DESCOVY	120MG;EQ 15MG BASE	TABLET / ORAL		RLD	2022-01-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208215-001	DESCOVY	200MG;EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208215-002	DESCOVY	120MG;EQ 15MG BASE	TABLET / ORAL		RLD	2022-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208215-001	DESCOVY	200MG;EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208215-002	DESCOVY	120MG;EQ 15MG BASE	TABLET / ORAL		RLD	2022-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208215-001	DESCOVY	200MG;EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208215-002	DESCOVY	120MG;EQ 15MG BASE	TABLET / ORAL		RLD	2022-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208215-001	DESCOVY	200MG;EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208215-002	DESCOVY	120MG;EQ 15MG BASE	TABLET / ORAL		RLD	2022-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208215-001	DESCOVY	200MG;EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-04-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208215-002	DESCOVY	120MG;EQ 15MG BASE	TABLET / ORAL		RLD	2022-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208215-001	DESCOVY	200MG;EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-04-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208215-002	DESCOVY	120MG;EQ 15MG BASE	TABLET / ORAL		RLD	2022-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208215-001	DESCOVY	200MG;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-04-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208215-002	DESCOVY	120MG;EQ 15MG BASE	TABLET / ORAL		RLD	2022-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208215-001	DESCOVY	200MG;EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-04-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208215-002	DESCOVY	120MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD	2022-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208215-001	DESCOVY	200MG;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-04-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208215-002	DESCOVY	120MG;EQ 15MG BASE	TABLET / ORAL		RLD	2022-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208215-001	DESCOVY	200MG;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-04-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208215-002	DESCOVY	120MG;EQ 15MG BASE	TABLET / ORAL		RLD	2022-01-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208215-001	DESCOVY	200MG;EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-04-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208215-002	DESCOVY	120MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD	2022-01-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208215-001	DESCOVY	200MG;EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-04-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208215-002	DESCOVY	120MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD	2022-01-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208215-001	DESCOVY	200MG;EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-04-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208215-002	DESCOVY	120MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD	2022-01-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208215-001	DESCOVY	200MG;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-04-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208215-002	DESCOVY	120MG;EQ 15MG BASE	TABLET / ORAL		RLD	2022-01-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208215-001	DESCOVY	200MG;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-04-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208215-002	DESCOVY	120MG;EQ 15MG BASE	TABLET / ORAL		RLD	2022-01-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208215-001	DESCOVY	200MG;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-04-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208215-002	DESCOVY	120MG;EQ 15MG BASE	TABLET / ORAL		RLD	2022-01-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208215-001	DESCOVY	200MG;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-04-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208215-002	DESCOVY	120MG;EQ 15MG BASE	TABLET / ORAL		RLD	2022-01-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208215-001	DESCOVY	200MG;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-04-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208215-001	DESCOVY	200MG;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-04-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208215-002	DESCOVY	120MG;EQ 15MG BASE	TABLET / ORAL		RLD	2022-01-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208215-001	DESCOVY	200MG;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-04-04	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N208215-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208215-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208215-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208215-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208215-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208215-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208215-001	AB	1	`03ed91905a0d…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208215-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208215-002	AB	1	`5bbf6a4d5a75…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208215-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208215-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208215-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208215-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208215-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208215-002	AB	1	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208215-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 16 · 620 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208215-001	8754065	2032-08-15	U-1259	Drug substance, Drug product	2016-05-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208215-001	8754065	2032-08-15	U-1663	Drug substance, Drug product	2016-05-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208215-001	8754065	2032-08-15	U-257	Drug substance, Drug product	2016-05-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208215-001	9296769	2032-08-15	U-257	Drug substance, Drug product	2016-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208215-001	9296769	2032-08-15	U-1259	Drug substance, Drug product	2016-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208215-001	9296769	2032-08-15	U-1663	Drug substance, Drug product	2016-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208215-001	8754065*PED	2033-02-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208215-001	9296769*PED	2033-02-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208215-001	12629338	2036-06-29		Drug product	2026-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208215-001	12648911	2036-06-29	U-1663		2026-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208215-001	12648911	2036-06-29	U-1259		2026-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208215-001	12661323	2036-06-29		Drug product	2026-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208215-001	12678408	2036-06-29		Drug product	2026-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208215-002	8754065	2032-08-15	U-1663	Drug substance, Drug product	2022-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208215-002	9296769	2032-08-15	U-1663	Drug substance, Drug product	2022-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208215-002	8754065*PED	2033-02-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208215-002	9296769*PED	2033-02-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208215-002	12661323	2036-06-29		Drug product	2026-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208215-001	8754065	2032-08-15	U-1259	Drug substance, Drug product	2016-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208215-001	8754065	2032-08-15	U-1663	Drug substance, Drug product	2016-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208215-001	8754065	2032-08-15	U-257	Drug substance, Drug product	2016-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208215-001	9296769	2032-08-15	U-257	Drug substance, Drug product	2016-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208215-001	9296769	2032-08-15	U-1259	Drug substance, Drug product	2016-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208215-001	9296769	2032-08-15	U-1663	Drug substance, Drug product	2016-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208215-001	8754065*PED	2033-02-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208215-001	9296769*PED	2033-02-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208215-002	8754065	2032-08-15	U-1663	Drug substance, Drug product	2022-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208215-002	9296769	2032-08-15	U-1663	Drug substance, Drug product	2022-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208215-002	8754065*PED	2033-02-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208215-002	9296769*PED	2033-02-15		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208215-001	7390791	2025-01-07		Drug substance, Drug product	2016-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208215-001	7390791*PED	2025-07-07		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208215-001	8754065	2032-08-15	U-1259	Drug substance, Drug product	2016-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208215-001	8754065	2032-08-15	U-1663	Drug substance, Drug product	2016-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208215-001	8754065	2032-08-15	U-257	Drug substance, Drug product	2016-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208215-001	9296769	2032-08-15	U-257	Drug substance, Drug product	2016-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208215-001	9296769	2032-08-15	U-1259	Drug substance, Drug product	2016-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208215-001	9296769	2032-08-15	U-1663	Drug substance, Drug product	2016-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208215-001	8754065*PED	2033-02-15		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208215-001	9296769*PED	2033-02-15		Pediatric extension		`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 118 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N208215-001	M-316	2028-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208215-001	ODE-556	2032-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208215-002	M-316	2028-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208215-002	ODE-554	2029-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208215-002	ODE-556	2032-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208215-001	M-316	2028-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208215-002	M-316	2028-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208215-002	ODE-457	2029-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208215-001	M-316	2028-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208215-002	M-316	2028-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208215-002	ODE-457	2029-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208215-002	ODE-457	2029-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208215-002	ODE-457	2029-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208215-002	ODE-457	2029-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208215-001	ODE-284	2024-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208215-001	ODE-285	2024-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208215-002	ODE-457	2029-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208215-001	ODE-284	2024-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208215-001	ODE-285	2024-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208215-002	ODE-457	2029-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208215-001	ODE-284	2024-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208215-001	ODE-285	2024-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208215-002	ODE-457	2029-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208215-001	ODE-284	2024-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208215-001	ODE-285	2024-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208215-002	ODE-457	2029-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208215-001	ODE-284	2024-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208215-001	ODE-285	2024-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208215-002	ODE-457	2029-01-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208215-001	ODE-284	2024-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208215-001	ODE-285	2024-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208215-002	ODE-457	2029-01-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208215-001	ODE-284	2024-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208215-001	ODE-285	2024-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208215-002	ODE-457	2029-01-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208215-001	ODE-284	2024-09-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208215-001	ODE-285	2024-09-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208215-002	ODE-457	2029-01-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208215-001	ODE-284	2024-09-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208215-001	ODE-285	2024-09-28	`8072bd15b7f6…`

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
DESCOVY	EMTRICITABINE AND TENOFOVIR ALAFENAMIDE	Gilead Sciences, Inc.	06f66e98-e6ee-4538-9506-6c1282cc14c1	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208215 application number: NDA208215

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G70B4ETF4S	EMTRICITABINE	143491-57-0	EMTRICITABINE
FWF6Q91TZO	TENOFOVIR ALAFENAMIDE FUMARATE	1392275-56-7	TENOFOVIR ALAFENAMIDE FUMARATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-0230-0	70518023000	30 TABLET in 1 BLISTER PACK (70518-0230-0)	30 tablet	2017-02-16	0000-00-00	No	No	Current