Efavirenz, emtricitabine and tenofovir disoproxil fumarate

Product NDC: 42385-915
11-digit product format: 423850915
Labeler code: 42385
Product ID: 42385-915_590152fa-ff7a-4db5-8e11-394c6b44c3c0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Efavirenz, emtricitabine and tenofovir disoproxil fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Laurus Labs Limited
Application: ANDA213541
Marketing category: ANDA
Marketing start: 2021-12-22
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2021-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213541-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213541-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2021-12-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213541-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213541-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213541-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213541-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213541-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213541-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213541-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213541-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213541-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213541-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213541-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213541-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213541-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213541-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213541-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213541-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213541-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213541-001	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213541-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213541-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213541-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213541-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213541-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213541-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213541-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213541-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213541-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213541-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213541-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213541-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213541-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213541-001	AB	1	`a50c72e98297…`

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
aca22076-f435-4533-9fcf-566b0734c313	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
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
42385-915-30	Efavirenz, emtricitabine and tenofovir disoproxil fumarate	30 in 1 BOTTLE	TABLET, FILM COATED	30		3
42385-915-90	Efavirenz, emtricitabine and tenofovir disoproxil fumarate	90 in 1 BOTTLE	TABLET, FILM COATED	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42385-915-30	EA - Each	42385-915	d19c64f4-752f-48b1-aa75-a937c6551fe9	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42385-915	EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [LAURUS LABS LIMITED]	2	Current NDC, Legacy NDC, 2 package rows	20240630_aca22076-f435-4533-9fcf-566b0734c313.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, emtricitabine and tenofovir disoproxil fumarate	EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Laurus Labs Limited	aca22076-f435-4533-9fcf-566b0734c313	2025-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213541 application number: ANDA213541 ndc (product): 42385-915

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	aca22076-f435-4533-9fcf-566b0734c313	3
643066	efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	SCD	aca22076-f435-4533-9fcf-566b0734c313	3
643066	efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet	SY	aca22076-f435-4533-9fcf-566b0734c313	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42385-915-30	42385091530	30 TABLET, FILM COATED in 1 BOTTLE (42385-915-30)	2021-12-22	0000-00-00	No	No	Current
42385-915-90	42385091590	90 TABLET, FILM COATED in 1 BOTTLE (42385-915-90)	2021-12-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Efavirenz, emtricitabine and tenofovir disoproxil fumarate	Laurus Labs Limited \| Laurus Labs Limited (VSP2)	2025-07-28	Human Prescription Drug Label	3