Atripla

Product NDC
50090-0980
11-digit product format
500900980
Labeler code
50090
Product ID
50090-0980_17a747c1-84bd-4288-bfdd-192566d37a1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
efavirenz, emtricitabine, and tenofovir disoproxil fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA021937
Marketing category
NDA
Marketing start
2006-07-20
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],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-0980DDiscontinued by firm2026-08-11
excluded packagepackage50090-098050090-0980-0DDiscontinued by firm2026-08-11

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-0980-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-0980-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-0980-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-0980-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-0980-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-0980-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-0980-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-0980-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-0980-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-0980-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-0980-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-0980-0557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021937-001ATRIPLAEFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE600MG;200MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-07-12

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021937-00190181922026-06-13U-11702015-05-28
N021937-00190181922026-06-13U-7502015-05-28
N021937-00195454142026-06-13U-1170Drug product2017-02-13
N021937-00195454142026-06-13U-750Drug product2017-02-13
N021937-00185981852029-04-28Drug product

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021937-001ATRIPLA600MG;200MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-07-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALRLD2006-07-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALRLD2006-07-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALRLD2006-07-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALRLD2006-07-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALRLD2006-07-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALRLD2006-07-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALRLD2006-07-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALRLD2006-07-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-1287673890dc5c…
2021-03-12 10:30 UTC2021-03N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-123f01610625f2…
2019-09-15 20:21 UTC2019-09N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-12b00525d2431f…
2019-07-19 19:46 UTC2019-07N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-123f0d92c62455…
2023-05-13 08:27 UTC2023-05N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-12053a50430f4f…
2023-01-26 05:58 UTC2023-01N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021937-001ATRIPLA600MG;200MG;300MGTABLET / ORALABRLD, RS2006-07-12cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021937-001AB15bbf6a4d5a75…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021937-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021937-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021937-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021937-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021937-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021937-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021937-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021937-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021937-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021937-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021937-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021937-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021937-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021937-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021937-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021937-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021937-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021937-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021937-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021937-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021937-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021937-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021937-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021937-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021937-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021937-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021937-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021937-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021937-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021937-001AB1cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 11 · 419 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021937-00190181922026-06-13U-7502015-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021937-00190181922026-06-13U-11702015-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021937-00195454142026-06-13U-1170Drug product2017-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021937-00195454142026-06-13U-750Drug product2017-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021937-00185981852029-04-28Drug product011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021937-00190181922026-06-13U-7502015-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021937-00190181922026-06-13U-11702015-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021937-00195454142026-06-13U-1170Drug product2017-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021937-00195454142026-06-13U-750Drug product2017-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021937-00185981852029-04-28Drug product31067a03dcf5…
2025-08-23 18:47 UTC2025-08N021937-00190181922026-06-13U-7502015-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021937-00190181922026-06-13U-11702015-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021937-00195454142026-06-13U-1170Drug product2017-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021937-00195454142026-06-13U-750Drug product2017-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021937-00185981852029-04-28Drug product6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021937-00190181922026-06-13U-7502015-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021937-00190181922026-06-13U-11702015-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021937-00195454142026-06-13U-1170Drug product2017-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021937-00195454142026-06-13U-750Drug product2017-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021937-00185981852029-04-28Drug productfd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021937-00190181922026-06-13U-7502015-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021937-00190181922026-06-13U-11702015-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021937-00195454142026-06-13U-1170Drug product2017-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021937-00195454142026-06-13U-750Drug product2017-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021937-00185981852029-04-28Drug productb8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021937-00185923972024-01-13U-1170Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021937-00185923972024-01-13U-750Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021937-00187162642024-01-13U-257Drug product2014-05-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021937-00194570362024-01-13U-257Drug product2016-11-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021937-00197441812024-01-13U-257Drug product2017-09-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021937-00190181922026-06-13U-7502015-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021937-00190181922026-06-13U-11702015-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021937-00195454142026-06-13U-1170Drug product2017-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021937-00195454142026-06-13U-750Drug product2017-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021937-00185981852029-04-28Drug product03ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021937-00185923972024-01-13U-1170Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021937-00185923972024-01-13U-750Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021937-00187162642024-01-13U-257Drug product2014-05-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021937-00194570362024-01-13U-257Drug product2016-11-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021937-00197441812024-01-13U-257Drug product2017-09-192680178bc6a6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0980-0EA - Each50090-09802b47ff40-05a6-401c-bcff-9fc690dbb41212018-10-11