Efavirenz

Product NDC: 65862-105
Requested package NDC: 65862-105-30
11-digit product format: 658620105
Labeler code: 65862
Product ID: 65862-105_a02dd4c8-6159-48b0-a79c-c362f1f4daf9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Efavirenz
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA078064
Marketing category: ANDA
Marketing start: 2017-12-15
Substance: EFAVIRENZ
Active strength: 100 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

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

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078064-001	EFAVIRENZ	50MG	CAPSULE / ORAL		2017-12-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078064-002	EFAVIRENZ	100MG	CAPSULE / ORAL		2017-12-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078064-003	EFAVIRENZ	200MG	CAPSULE / ORAL	RS	2017-12-15	`84e616aacf4f…`
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…`

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…`

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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EFAVIRENZ	100 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
205290	Internal RxNorm lookup
205291	Internal RxNorm lookup
205292	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
4c57ad7f-321a-46c8-851a-c895466eb8e1	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
65862-105-10	Efavirenz	10 in 1 BLISTER PACK	CAPSULE	10	7
65862-105-10	Efavirenz	3 in 1 CARTON	CAPSULE	3	7
65862-105-30	Efavirenz	30 in 1 BOTTLE	CAPSULE	30	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-105	EFAVIRENZ CAPSULE [AUROBINDO PHARMA LIMITED]	7	Current NDC, Legacy NDC, 3 package rows	20240104_4c57ad7f-321a-46c8-851a-c895466eb8e1.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	4c57ad7f-321a-46c8-851a-c895466eb8e1	2023-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078064 application number: ANDA078064 ndc (package): 65862-105-30 ndc (product): 65862-105 ndc11 (package): 65862010530

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
205291	efavirenz 100 MG Oral Capsule	PSN	4c57ad7f-321a-46c8-851a-c895466eb8e1	7
205290	efavirenz 200 MG Oral Capsule	PSN	4c57ad7f-321a-46c8-851a-c895466eb8e1	7
205292	efavirenz 50 MG Oral Capsule	PSN	4c57ad7f-321a-46c8-851a-c895466eb8e1	7
205291	efavirenz 100 MG Oral Capsule	SCD	4c57ad7f-321a-46c8-851a-c895466eb8e1	7
205290	efavirenz 200 MG Oral Capsule	SCD	4c57ad7f-321a-46c8-851a-c895466eb8e1	7
205292	efavirenz 50 MG Oral Capsule	SCD	4c57ad7f-321a-46c8-851a-c895466eb8e1	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-105-30	65862010530	30 CAPSULE in 1 BOTTLE (65862-105-30)	30 capsule	2017-12-15	0000-00-00	No	No	Current