COMPLERA

Product NDC: 70518-0677
11-digit product format: 705180677
Labeler code: 70518
Product ID: 70518-0677_c72f2363-1f66-cecd-e053-2a95a90ae524
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: NDA202123
Marketing category: NDA
Marketing start: 2017-08-16
Marketing end: 0000-00-00
Substance: EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
Active strength: 200 mg/1; 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 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Non-Nucleoside Analog [EXT],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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70518-0677		D	Discontinued by firm	2026-08-11
excluded package	package	70518-0677	70518-0677-0	D	Discontinued by firm	2026-08-11
excluded package	package	70518-0677	70518-0677-1	D	Discontinued by firm	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 · 36 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	70518-0677-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-0677-1	`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	70518-0677-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-0677-1	`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	70518-0677-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-0677-1	`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	70518-0677-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-0677-1	`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	70518-0677-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-0677-1	`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	70518-0677-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-0677-1	`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	70518-0677-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-0677-1	`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	70518-0677-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-0677-1	`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	70518-0677-0	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-0677-1	`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	70518-0677-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-0677-1	`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	70518-0677-0	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-0677-1	`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	70518-0677-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-0677-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N202123-001	COMPLERA	EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE	200MG;EQ 25MG BASE;300MG	TABLET / ORAL	AB	RLD, RS	2011-08-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N202123-001	AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202123-001	10857102	2033-01-14		Drug product	2021-01-06

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	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL	AB	RLD, RS	2011-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL	AB	RLD, RS	2011-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL	AB	RLD, RS	2011-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202123-001	COMPLERA	200MG;EQ 25MG BASE;300MG	TABLET / ORAL		RLD, RS	2011-08-10	`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	N202123-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202123-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202123-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202123-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 341 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	N202123-001	10857102	2033-01-14		Drug product	2021-01-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202123-001	7125879	2025-04-21	U-257	Drug substance, Drug product	2011-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202123-001	8841310	2025-12-09	U-257	Drug product	2014-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202123-001	10857102	2033-01-14		Drug product	2021-01-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202123-001	7125879	2025-04-21	U-257	Drug substance, Drug product	2011-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202123-001	8841310	2025-12-09	U-257	Drug product	2014-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202123-001	10857102	2033-01-14		Drug product	2021-01-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202123-001	7125879	2025-04-21	U-257	Drug substance, Drug product	2011-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202123-001	8841310	2025-12-09	U-257	Drug product	2014-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202123-001	10857102	2033-01-14		Drug product	2021-01-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202123-001	7125879	2025-04-21	U-257	Drug substance, Drug product	2011-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202123-001	8841310	2025-12-09	U-257	Drug product	2014-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202123-001	10857102	2033-01-14		Drug product	2021-01-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202123-001	8592397	2024-01-13	U-257	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202123-001	8716264	2024-01-13	U-257	Drug product	2014-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202123-001	9457036	2024-01-13	U-257	Drug product	2016-11-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202123-001	9744181	2024-01-13	U-257	Drug product	2017-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202123-001	7125879	2025-04-21	U-257	Drug substance, Drug product	2011-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202123-001	8841310	2025-12-09	U-257	Drug product	2014-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202123-001	10857102	2033-01-14		Drug product	2021-01-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202123-001	8592397	2024-01-13	U-257	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202123-001	8716264	2024-01-13	U-257	Drug product	2014-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202123-001	9457036	2024-01-13	U-257	Drug product	2016-11-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202123-001	9744181	2024-01-13	U-257	Drug product	2017-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202123-001	7125879	2025-04-21	U-257	Drug substance, Drug product	2011-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202123-001	8841310	2025-12-09	U-257	Drug product	2014-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202123-001	10857102	2033-01-14		Drug product	2021-01-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202123-001	8592397	2024-01-13	U-257	Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202123-001	8716264	2024-01-13	U-257	Drug product	2014-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202123-001	9457036	2024-01-13	U-257	Drug product	2016-11-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202123-001	9744181	2024-01-13	U-257	Drug product	2017-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202123-001	7125879	2025-04-21	U-257	Drug substance, Drug product	2011-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202123-001	8841310	2025-12-09	U-257	Drug product	2014-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202123-001	10857102	2033-01-14		Drug product	2021-01-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202123-001	8592397	2024-01-13	U-257	Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202123-001	8716264	2024-01-13	U-257	Drug product	2014-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202123-001	9457036	2024-01-13	U-257	Drug product	2016-11-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202123-001	9744181	2024-01-13	U-257	Drug product	2017-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202123-001	7125879	2025-04-21	U-257	Drug substance, Drug product	2011-09-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202123-001	8841310	2025-12-09	U-257	Drug product	2014-10-20	`d8e5a09893c0…`

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
COMPLERA	EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE	Gilead Sciences, Inc.	d637cfab-f1e8-4eb3-a1b3-f85ca3bec612	2025-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202123 application number: NDA202123

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
OTT9J7900I	TENOFOVIR DISOPROXIL FUMARATE	202138-50-9	TENOFOVIR DISOPROXIL FUMARATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-0677-1	70518067701	30 POUCH in 1 BOX (70518-0677-1) > 1 TABLET, FILM COATED in 1 POUCH (70518-0677-2)	30 pouch	2021-07-15	0000-00-00	No	No	Current