Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate

Product NDC: 65862-497
11-digit product format: 658620497
Labeler code: 65862
Product ID: 65862-497_e45a9953-97a0-4885-acbd-5af0f22c4f74
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA203041
Marketing category: ANDA
Marketing start: 2021-03-30
Substance: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength: 600; 200; 300 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: 2026-12-31
Current FDA listing: Yes

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
unfinished product	product	65862-497		UNFINISHED	Active or certified unfinished drug listing		2026-10-05
unfinished package	package	65862-497	65862-497-13	UNFINISHED	Active or certified unfinished drug listing		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 · 32 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 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-497-13	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-497-13	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-497-13	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-497-13	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-497-13	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-497-13	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-497-13	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-497-13	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-497-13	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-497-13	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-497-13	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-497-13	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-497-13	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-497-13	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-497-13	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	65862-497-13	`6db9cb8d1e19…`	`3449e1ec5b70…`

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
A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	RS	2018-09-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203041-001	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	RS	2018-09-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	RS	2018-09-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	RS	2018-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	RS	2018-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	RS	2018-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	RS	2018-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	RS	2018-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	RS	2018-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	RS	2018-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	RS	2018-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	RS	2018-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203041-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2018-09-04	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203041-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203041-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203041-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203041-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203041-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203041-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203041-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203041-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203041-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203041-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203041-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203041-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203041-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203041-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203041-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203041-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203041-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203041-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203041-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203041-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203041-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203041-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203041-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203041-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203041-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203041-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203041-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203041-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203041-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203041-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203041-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203041-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203041-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203041-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203041-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203041-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203041-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203041-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203041-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203041-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EFAVIRENZ	600 mg/1
EMTRICITABINE	200 mg/1
TENOFOVIR DISOPROXIL FUMARATE	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JE6H2O27P8	Internal UNII lookup
G70B4ETF4S	Internal UNII lookup
OTT9J7900I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
643066	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
1b71df95-b1ce-4e40-908a-67fb336457f4	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
649b204e-4c3b-7f17-657b-ae3f2995e611	Product name	7	20250220
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
03a109f6-6ebe-4ce1-a7d1-c1e0e0cbeb0b	Product name	1	20180221
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
65862-497-30	Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate	30 in 1 BOTTLE	TABLET, FILM COATED	30		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-497-30	EA - Each	65862-497	7201e5be-6a08-4da3-b0ac-fa6d1a3c7545	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-497	EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5	Current NDC, Legacy NDC, 1 package rows	20231229_1b71df95-b1ce-4e40-908a-67fb336457f4.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 · 2 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	Bryant Ranch Prepack	ec61f069-632e-4628-b9b1-701d381a1a06	2025-11-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203041 application number: ANDA203041
Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate	EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Aurobindo Pharma Limited	1b71df95-b1ce-4e40-908a-67fb336457f4	2023-12-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203041 application number: ANDA203041 ndc (product): 65862-497

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
643066	efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	PSN	ec61f069-632e-4628-b9b1-701d381a1a06	100
643066	efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	SCD	ec61f069-632e-4628-b9b1-701d381a1a06	100
643066	efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet	SY	ec61f069-632e-4628-b9b1-701d381a1a06	100
643066	efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	PSN	1b71df95-b1ce-4e40-908a-67fb336457f4	5
643066	efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	SCD	1b71df95-b1ce-4e40-908a-67fb336457f4	5
643066	efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet	SY	1b71df95-b1ce-4e40-908a-67fb336457f4	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-497-13	65862049713	1400 TABLET, FILM COATED in 1 BAG (65862-497-13)	30-MAR-21				Current
65862-497-30	65862049730	30 TABLET, FILM COATED in 1 BOTTLE (65862-497-30)	2021-03-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate	Bryant Ranch Prepack	2025-11-04	HUMAN PRESCRIPTION DRUG LABEL	100
Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate	Aurobindo Pharma Limited	2023-12-28	Human Prescription Drug Label	5