efavirenz, emtricitabine and tenofovir disoproxil fumarate

Product NDC: 76282-678
Requested package NDC: 76282-678-30
11-digit product format: 762820678
Labeler code: 76282
Product ID: 76282-678_4e4963e8-6ffd-4b2d-8826-ed63cd51db16
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: efavirenz, emtricitabine and tenofovir disoproxil fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Exelan Pharmaceuticals, Inc.
Application: ANDA206894
Marketing category: ANDA
Marketing start: 2021-03-30
Marketing end: 0000-00-00
Substance: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength: 600 mg/1; mg/1; mg/1
Pharmacologic classes: Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [EXT],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	76282-678	76282-678-30	I	Inactivated by FDA		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 · 15 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…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB		2019-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206894-001	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	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206894-001	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	600MG;200MG;300MG	TABLET / ORAL	AB	2019-06-03	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206894-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206894-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206894-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206894-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206894-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206894-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206894-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206894-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206894-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206894-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206894-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206894-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206894-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206894-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206894-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206894-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206894-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206894-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206894-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206894-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206894-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206894-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206894-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206894-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206894-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206894-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206894-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206894-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206894-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206894-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206894-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206894-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206894-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206894-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206894-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206894-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206894-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206894-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206894-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206894-001	AB	1	`e64feba35796…`

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
4ef90d80-1289-4267-a2bb-01c741d1208f	Product name	1	20230829
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	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
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
d1784558-3c5f-4d73-8a7c-051102bb6c92	Product name	1	20160405
7fd46899-3505-4ed4-b856-6b2509a76004	Product name	1	20151123
0583b5e6-2e6e-c94b-9ff6-81a81ba199de	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76282-678-30	2023-01-30	C162847	48780-1	f386c64a-43ac-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE TABLET safely and effectively. See full prescribing information for EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE TABLET. EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE tablets, for oral use Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76282-678-30	efavirenz, emtricitabine and tenofovir disoproxil fumarate	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76282-678-30	EA - Each	76282-678	d8b8e878-8b42-4530-8f22-3487668847ca	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76282-678	EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]	1	Legacy NDC, 1 package rows	20210330_1e81fa46-1164-4a34-b212-dcc16f3dc2c6.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	Cipla USA Inc.	a7d94a1c-31b0-4272-8f8d-186d580e16e0	2021-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206894 application number: ANDA206894

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	1e81fa46-1164-4a34-b212-dcc16f3dc2c6	1
643066	efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	SCD	1e81fa46-1164-4a34-b212-dcc16f3dc2c6	1
643066	efavirenz 600 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet	SY	1e81fa46-1164-4a34-b212-dcc16f3dc2c6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
76282-678-30	76282067830	30 TABLET, FILM COATED in 1 BOTTLE (76282-678-30)	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	Exelan Pharmaceuticals, Inc. \| Genvion Corporation 500 Camiel Sys Street, Winnipeg, Manitoba R2J 4K2, Canada	2021-03-12	HUMAN PRESCRIPTION DRUG LABEL	1