ODEFSEY

Product NDC: 50090-2340
11-digit product format: 500902340
Labeler code: 50090
Product ID: 50090-2340_26120f57-70c4-4368-81de-9167e306a0a4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: emtricitabine, rilpivirine, and tenofovir alafenamide
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA208351
Marketing category: NDA
Marketing start: 2016-03-01
Marketing end: 0000-00-00
Substance: EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE
Active strength: 200 mg/1; mg/1; mg/1
Pharmacologic classes: Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Non-Nucleoside Analog [EXT],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
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	50090-2340		I	Inactivated by FDA		2026-08-11
excluded package	package	50090-2340	50090-2340-0	I	Inactivated by FDA		2026-08-11

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 · 42 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	50090-2340-0	`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	50090-2340-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-2340-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-2340-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-2340-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-2340-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-2340-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-2340-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-2340-0	`0efc9e666f02…`	`f202fb6c5f17…`
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	50090-2340-0	`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	50090-2340-0	`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	50090-2340-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-2340-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-2340-0	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-2340-0	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50090-2340-0	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50090-2340-0	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50090-2340-0	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50090-2340-0	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	50090-2340-0	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	50090-2340-0	`9bebd1f3094a…`	`5416666fcb17…`

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
N208351-001	ODEFSEY	EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-03-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N208351-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208351-001	8754065	2032-08-15	U-257	Drug substance, Drug product	2016-03-24
N208351-001	9296769	2032-08-15	U-257	Drug substance, Drug product	2016-04-19
N208351-001	8754065*PED	2033-02-15		Pediatric extension
N208351-001	9296769*PED	2033-02-15		Pediatric extension

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	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208351-001	ODEFSEY	200MG;EQ 25MG BASE;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-03-01	`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	N208351-001	AB	1	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208351-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 363 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	N208351-001	8754065	2032-08-15	U-257	Drug substance, Drug product	2016-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208351-001	9296769	2032-08-15	U-257	Drug substance, Drug product	2016-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208351-001	8754065*PED	2033-02-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208351-001	9296769*PED	2033-02-15		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208351-001	7390791	2025-01-07		Drug substance, Drug product	2016-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208351-001	7125879	2025-04-21	U-257	Drug substance, Drug product	2016-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208351-001	7390791*PED	2025-07-07		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208351-001	8754065	2032-08-15	U-257	Drug substance, Drug product	2016-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208351-001	9296769	2032-08-15	U-257	Drug substance, Drug product	2016-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208351-001	8754065*PED	2033-02-15		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208351-001	9296769*PED	2033-02-15		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208351-001	7390791	2025-01-07		Drug substance, Drug product	2016-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208351-001	7125879	2025-04-21	U-257	Drug substance, Drug product	2016-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208351-001	7390791*PED	2025-07-07		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208351-001	8754065	2032-08-15	U-257	Drug substance, Drug product	2016-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208351-001	9296769	2032-08-15	U-257	Drug substance, Drug product	2016-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208351-001	8754065*PED	2033-02-15		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208351-001	9296769*PED	2033-02-15		Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208351-001	7390791	2025-01-07		Drug substance, Drug product	2016-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208351-001	7125879	2025-04-21	U-257	Drug substance, Drug product	2016-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208351-001	7390791*PED	2025-07-07		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208351-001	8754065	2032-08-15	U-257	Drug substance, Drug product	2016-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208351-001	9296769	2032-08-15	U-257	Drug substance, Drug product	2016-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208351-001	8754065*PED	2033-02-15		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208351-001	9296769*PED	2033-02-15		Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208351-001	7390791	2025-01-07		Drug substance, Drug product	2016-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208351-001	7125879	2025-04-21	U-257	Drug substance, Drug product	2016-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208351-001	7390791*PED	2025-07-07		Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208351-001	8754065	2032-08-15	U-257	Drug substance, Drug product	2016-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208351-001	9296769	2032-08-15	U-257	Drug substance, Drug product	2016-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208351-001	8754065*PED	2033-02-15		Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208351-001	9296769*PED	2033-02-15		Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208351-001	7390791	2025-04-17		Drug substance, Drug product	2016-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208351-001	7125879	2025-04-21	U-257	Drug substance, Drug product	2016-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208351-001	7390791*PED	2025-10-17		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208351-001	8754065	2032-08-15	U-257	Drug substance, Drug product	2016-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208351-001	9296769	2032-08-15	U-257	Drug substance, Drug product	2016-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208351-001	8754065*PED	2033-02-15		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208351-001	9296769*PED	2033-02-15		Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208351-001	7390791	2025-04-17		Drug substance, Drug product	2016-03-24	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208351-001	M-206	2020-08-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208351-001	M-207	2020-08-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208351-001	NCE	2020-11-05	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N208351-001	M-206	2020-08-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208351-001	M-207	2020-08-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208351-001	NCE	2020-11-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208351-001	M-206	2020-08-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208351-001	M-207	2020-08-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208351-001	NCE	2020-11-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208351-001	M-206	2020-08-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208351-001	M-207	2020-08-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208351-001	NCE	2020-11-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208351-001	M-206	2020-08-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208351-001	M-207	2020-08-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208351-001	NCE	2020-11-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208351-001	M-206	2020-08-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208351-001	M-207	2020-08-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208351-001	NCE	2020-11-05	`ea99ee380514…`

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
38d19fab-47e8-d825-5329-4948eaa6d686	Product name	2	20250124
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
1cd1fd33-94db-4c45-bd26-82773ea350a3	Product name	2	20220317
14397d46-1c8c-bbf7-f4b7-5a7e59d3690f	Product name	4	20220314
f306ec07-0d7d-45ce-ade0-e6c8659560b1	Product name	1	20210621
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
44633898-5724-4273-abcc-3541a1107946	Product name	1	20180124
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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-2340-0	2020-01-31	C162847	48780-1	9d75b9d0-ba76-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use ODEFSEY safely and effectively. See full prescribing information for ODEFSEY. ODEFSEY ® (emtricitabine, rilpivirine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2016

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-2340-0	ODEFSEY	30 in 1 BOTTLE, PLASTIC	TABLET	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-2340-0	EA - Each	50090-2340	63d4c8c8-bc27-441c-bf3f-d9858afa8413	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-2340	ODEFSEY (EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE) TABLET [A-S MEDICATION SOLUTIONS]	4	Legacy NDC, 1 package rows	20190225_f8689541-6526-47a5-9ff5-b8fc39ef4099.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
ODEFSEY	EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR ALAFENAMIDE	Gilead Sciences, Inc.	ea3b9ec8-e04a-412c-8b3f-e5cbc7e641d5	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208351 application number: NDA208351

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G70B4ETF4S	EMTRICITABINE	143491-57-0	EMTRICITABINE
212WAX8KDD	RILPIVIRINE HYDROCHLORIDE	700361-47-3	RILPIVIRINE HYDROCHLORIDE
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
1741733	emtricitabine 200 MG / rilpivirine 25 MG / tenofovir alafenamide 25 MG Oral Tablet	PSN	f8689541-6526-47a5-9ff5-b8fc39ef4099	4
1741739	ODEFSEY 200 MG / 25 MG/ 25 MG Oral Tablet	PSN	f8689541-6526-47a5-9ff5-b8fc39ef4099	4
1741739	emtricitabine 200 MG / rilpivirine 25 MG / tenofovir alafenamide 25 MG Oral Tablet [Odefsey]	SBD	f8689541-6526-47a5-9ff5-b8fc39ef4099	4
1741733	emtricitabine 200 MG / rilpivirine 25 MG / tenofovir alafenamide 25 MG Oral Tablet	SCD	f8689541-6526-47a5-9ff5-b8fc39ef4099	4
1741733	emtricitabine 200 MG / rilpivirine 25 MG (as rilpivirine HCl 27.5 MG) / tenofovir alafenamide 25 MG (as tenofovir alafenamide fumarate 28 MG) Oral Tablet	SY	f8689541-6526-47a5-9ff5-b8fc39ef4099	4
1741739	Odefsey (emtricitabine 200 MG / rilpivirine 25 MG (as rilpivirine HCl 27.5 MG) / tenofovir alafenamide 25 MG (as tenofovir alafenamide fumarate 28 MG)) Oral Tablet	SY	f8689541-6526-47a5-9ff5-b8fc39ef4099	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50090-2340-0	50090234000	30 in 1 BOTTLE, PLASTIC	Historical