Efavirenz

Product NDC: 65862-049
11-digit product format: 658620049
Labeler code: 65862
Product ID: 65862-049_f9982eb1-1e15-4fad-99f9-0f9da04fd058
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Efavirenz
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA077673
Marketing category: ANDA
Marketing start: 2018-09-21
Substance: EFAVIRENZ
Active strength: 600 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], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
unfinished product	product	65862-049		UNFINISHED	Active or certified unfinished drug listing	2026-08-17
unfinished package	package	65862-049	65862-049-15	UNFINISHED	Active or certified unfinished drug listing	2026-08-17
unfinished package	package	65862-049	65862-049-99	UNFINISHED	Active or certified unfinished drug listing	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 2 · 63 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	65862-049-15	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-049-99	`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	65862-049-15	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-049-99	`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	65862-049-15	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-049-99	`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	65862-049-15	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-049-99	`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	65862-049-15	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-049-99	`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	65862-049-15	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-049-99	`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	65862-049-15	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-049-99	`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	65862-049-15	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-049-99	`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	65862-049-15	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-049-99	`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	65862-049-15	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-049-99	`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	65862-049-15	`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-049-99	`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	65862-049-15	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-049-99	`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	65862-049-15	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-049-99	`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	65862-049-15	`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-049-99	`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	65862-049-15	`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-049-99	`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	65862-049-15	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	65862-049-99	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	65862-049-15	`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	65862-049-99	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	65862-049-99	`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	65862-049-15	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	65862-049-99	`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	65862-049-15	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	65862-049-15	`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	65862-049-99	`263afe128892…`	`91768de4ddbe…`

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

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
A077673-001	EFAVIRENZ	EFAVIRENZ	600MG	TABLET / ORAL	AB		2018-09-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077673-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL		2018-09-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL		2018-09-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL		2018-09-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL		2018-09-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077673-001	EFAVIRENZ	600MG	TABLET / ORAL	AB	2018-09-21	`e64feba35796…`

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	A077673-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077673-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077673-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077673-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077673-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077673-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077673-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077673-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077673-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077673-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077673-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077673-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077673-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077673-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077673-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077673-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077673-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077673-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A077673-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077673-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077673-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077673-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077673-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077673-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077673-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077673-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077673-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077673-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077673-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077673-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077673-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077673-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077673-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077673-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077673-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077673-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077673-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077673-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Efavirenz
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EFAVIRENZ	600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349477	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
c5eedb5d-4cab-4056-a14a-ffdf67701355	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
649b204e-4c3b-7f17-657b-ae3f2995e611	Product name	7	20250220
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
03a109f6-6ebe-4ce1-a7d1-c1e0e0cbeb0b	Product name	1	20180221

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65862-049-10	Efavirenz	3 in 1 CARTON	TABLET, FILM COATED	3	10
65862-049-10	Efavirenz	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	10
65862-049-30	Efavirenz	30 in 1 BOTTLE	TABLET, FILM COATED	30	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-049-30	EA - Each	65862-049	0592e188-cf40-42e8-99ce-9d4d721c8bd7	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-049	EFAVIRENZ TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	10	Current NDC, Legacy NDC, 3 package rows	20240104_c5eedb5d-4cab-4056-a14a-ffdf67701355.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
Efavirenz	EFAVIRENZ	Aurobindo Pharma Limited	c5eedb5d-4cab-4056-a14a-ffdf67701355	2023-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077673 application number: ANDA077673 ndc (product): 65862-049

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JE6H2O27P8	EFAVIRENZ	154598-52-4	EFAVIRENZ

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349477	efavirenz 600 MG Oral Tablet	PSN	c5eedb5d-4cab-4056-a14a-ffdf67701355	10
349477	efavirenz 600 MG Oral Tablet	SCD	c5eedb5d-4cab-4056-a14a-ffdf67701355	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-049-10	65862004910	3 BLISTER PACK in 1 CARTON (65862-049-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK	3 blister pack	2018-09-21	0000-00-00	No	No	Current
65862-049-15	65862004915	1500 TABLET, FILM COATED in 1 BAG (65862-049-15)		21-SEP-18				Current
65862-049-30	65862004930	30 TABLET, FILM COATED in 1 BOTTLE (65862-049-30)		2018-09-21	0000-00-00	No	No	Current
65862-049-99	65862004999	1000 TABLET, FILM COATED in 1 BAG (65862-049-99)		21-SEP-18				Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Efavirenz	REMEDYREPACK INC.	2024-03-14	HUMAN PRESCRIPTION DRUG LABEL	4
Efavirenz	Aurobindo Pharma Limited	2023-12-29	Human Prescription Drug Label	10