Efavirenz

Product NDC: 64980-406
Requested package NDC: 64980-406-03
11-digit product format: 649800406
Labeler code: 64980
Product ID: 64980-406_6267ce9b-6ae9-47ae-835c-567963f6477a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Efavirenz
Dosage form: CAPSULE
Route: ORAL
Labeler: Rising Pharmaceuticals, Inc.
Application: ANDA078064
Marketing category: ANDA
Marketing start: 2017-12-15
Marketing end: 0000-00-00
Substance: EFAVIRENZ
Active strength: 50 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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	64980-406	64980-406-03	D	Discontinued by firm		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 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
A078064-001	EFAVIRENZ	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15
A078064-002	EFAVIRENZ	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15
A078064-003	EFAVIRENZ	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15

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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078064-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078064-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078064-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078064-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078064-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078064-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078064-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078064-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078064-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078064-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078064-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078064-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078064-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078064-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078064-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078064-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078064-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078064-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078064-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078064-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078064-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078064-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078064-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078064-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078064-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078064-003	AB	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A078064-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A078064-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078064-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078064-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078064-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A078064-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078064-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A078064-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078064-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078064-003	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64980-406-03	EA - Each	64980-406	d1cf8b1f-dfb3-48c5-9c11-12cd9d254b60	1	2018-01-12

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	4c57ad7f-321a-46c8-851a-c895466eb8e1	2023-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078064 application number: ANDA078064

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64980-406-03	64980040603	30 CAPSULE in 1 BOTTLE (64980-406-03)	30 capsule	2017-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Efavirenz	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2024-03-19	Human Prescription Drug Label	7