Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate

Product NDC: 70518-2905
11-digit product format: 705182905
Labeler code: 70518
Product ID: 70518-2905_d797596d-95a8-9985-e053-2995a90a6daa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA091215
Marketing category: ANDA
Marketing start: 2020-10-15
Marketing end: 0000-00-00
Substance: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength: 600 mg/1; mg/1; mg/1
Pharmacologic classes: Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	70518-2905		D	Discontinued by firm		2026-10-05
excluded package	package	70518-2905	70518-2905-0	D	Discontinued by firm		2026-10-05

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 · 22 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	70518-2905-0	`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	70518-2905-0	`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	70518-2905-0	`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	70518-2905-0	`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	70518-2905-0	`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	70518-2905-0	`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	70518-2905-0	`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	70518-2905-0	`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	70518-2905-0	`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	70518-2905-0	`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	70518-2905-0	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091215-001	AB

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL		2018-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL		2018-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL		2018-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL		2018-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091215-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2018-11-09	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091215-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091215-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091215-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091215-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091215-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091215-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091215-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091215-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091215-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091215-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091215-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091215-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091215-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091215-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091215-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091215-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091215-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091215-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091215-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A091215-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091215-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091215-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091215-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091215-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091215-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091215-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091215-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091215-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091215-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091215-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091215-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091215-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091215-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091215-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091215-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091215-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091215-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091215-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A091215-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2905-0	2022-02-09	C162847	48780-1	d6a99b39-cad1-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS safely and effectively. See full prescribing information for EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS. EFAVIRENZ, EMTRICITABINE and TENOFOVIR DISOPROXIL FUMARATE tablets, for oral use Initial U.S. Approval: 2006
70518-2905-0	2022-01-28	C162847	48780-1	d6a99b39-cad1-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS safely and effectively. See full prescribing information for EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS. EFAVIRENZ, EMTRICITABINE and TENOFOVIR DISOPROXIL FUMARATE tablets, for oral use Initial U.S. Approval: 2006

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
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate	EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Teva Pharmaceuticals USA, Inc.	fc9c2149-8d40-401b-af13-5ae7f953950a	2024-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091215 application number: ANDA091215

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JE6H2O27P8	EFAVIRENZ	154598-52-4	EFAVIRENZ
G70B4ETF4S	EMTRICITABINE	143491-57-0	EMTRICITABINE
OTT9J7900I	TENOFOVIR DISOPROXIL FUMARATE	202138-50-9	TENOFOVIR DISOPROXIL FUMARATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2905-0	70518290500	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2905-0)	2020-10-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate	REMEDYREPACK INC.	2024-03-07	HUMAN PRESCRIPTION DRUG LABEL	4