Home NDC 70518-0341 Atripla
Product NDC 70518-0341
11-digit product format 705180341
Labeler code 70518
Product ID 70518-0341_e15694cd-e146-494a-e053-2a95a90ab52d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name efavirenz, emtricitabine, and tenofovir disoproxil fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application NDA021937
Marketing category NDA
Marketing start 2017-03-20
Marketing end 0000-00-00
Substance EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength 600 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 2023-12-31
Current FDA listing Historical FDA.report record 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 date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-0341-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70518-0341-0 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 70518-0341-0 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 70518-0341-0 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 70518-0341-0 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 70518-0341-0 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 70518-0341-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 70518-0341-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 70518-0341-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70518-0341-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70518-0341-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70518-0341-0 557ba5c1ecfa…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021937-001 ATRIPLA EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 600MG;200MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-07-12
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021937-001 9018192 2026-06-13 U-1170 2015-05-28 N021937-001 9018192 2026-06-13 U-750 2015-05-28 N021937-001 9545414 2026-06-13 U-1170 Drug product 2017-02-13 N021937-001 9545414 2026-06-13 U-750 Drug product 2017-02-13 N021937-001 8598185 2029-04-28 Drug 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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021937-001 ATRIPLA 600MG;200MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-07-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL RLD 2006-07-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL RLD 2006-07-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL RLD 2006-07-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL RLD 2006-07-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL RLD 2006-07-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL RLD 2006-07-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL RLD 2006-07-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL RLD 2006-07-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021937-001 ATRIPLA 600MG;200MG;300MG TABLET / ORAL AB RLD, RS 2006-07-12 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 11 · 419 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021937-001 9018192 2026-06-13 U-750 2015-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021937-001 9018192 2026-06-13 U-1170 2015-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021937-001 9545414 2026-06-13 U-1170 Drug product 2017-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021937-001 9545414 2026-06-13 U-750 Drug product 2017-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021937-001 8598185 2029-04-28 Drug product 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021937-001 9018192 2026-06-13 U-750 2015-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021937-001 9018192 2026-06-13 U-1170 2015-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021937-001 9545414 2026-06-13 U-1170 Drug product 2017-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021937-001 9545414 2026-06-13 U-750 Drug product 2017-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021937-001 8598185 2029-04-28 Drug product 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021937-001 9018192 2026-06-13 U-750 2015-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021937-001 9018192 2026-06-13 U-1170 2015-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021937-001 9545414 2026-06-13 U-1170 Drug product 2017-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021937-001 9545414 2026-06-13 U-750 Drug product 2017-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021937-001 8598185 2029-04-28 Drug product 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021937-001 9018192 2026-06-13 U-750 2015-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021937-001 9018192 2026-06-13 U-1170 2015-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021937-001 9545414 2026-06-13 U-1170 Drug product 2017-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021937-001 9545414 2026-06-13 U-750 Drug product 2017-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021937-001 8598185 2029-04-28 Drug product fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021937-001 9018192 2026-06-13 U-750 2015-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021937-001 9018192 2026-06-13 U-1170 2015-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021937-001 9545414 2026-06-13 U-1170 Drug product 2017-02-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021937-001 9545414 2026-06-13 U-750 Drug product 2017-02-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021937-001 8598185 2029-04-28 Drug product b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021937-001 8592397 2024-01-13 U-1170 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021937-001 8592397 2024-01-13 U-750 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021937-001 8716264 2024-01-13 U-257 Drug product 2014-05-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021937-001 9457036 2024-01-13 U-257 Drug product 2016-11-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021937-001 9744181 2024-01-13 U-257 Drug product 2017-09-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021937-001 9018192 2026-06-13 U-750 2015-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021937-001 9018192 2026-06-13 U-1170 2015-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021937-001 9545414 2026-06-13 U-1170 Drug product 2017-02-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021937-001 9545414 2026-06-13 U-750 Drug product 2017-02-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021937-001 8598185 2029-04-28 Drug product 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021937-001 8592397 2024-01-13 U-1170 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021937-001 8592397 2024-01-13 U-750 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021937-001 8716264 2024-01-13 U-257 Drug product 2014-05-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021937-001 9457036 2024-01-13 U-257 Drug product 2016-11-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021937-001 9744181 2024-01-13 U-257 Drug product 2017-09-19 2680178bc6a6…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70518-0341-0 70518034100 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0341-0) 2017-03-20 0000-00-00 No No Current