Home NDC 71335-0681 Armodafinil
Product NDC 71335-0681
11-digit product format 713350681
Labeler code 71335
Product ID 71335-0681_d8558bc2-6354-454a-81e9-3fad93f276f5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Armodafinil
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA200751
Marketing category ANDA
Marketing start 2016-11-28
Marketing end 0000-00-00
Substance ARMODAFINIL
Active strength 150 mg/1
DEA schedule CIV
NDC exclude flag No
Listing certified through 2021-12-31
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 · 55 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71335-0681-2 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71335-0681-1 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71335-0681-3 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71335-0681-2 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71335-0681-1 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71335-0681-3 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71335-0681-2 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71335-0681-1 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71335-0681-3 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71335-0681-2 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71335-0681-1 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71335-0681-3 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71335-0681-2 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71335-0681-1 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71335-0681-3 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 71335-0681-2 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 71335-0681-1 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 71335-0681-3 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 71335-0681-2 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 71335-0681-1 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 71335-0681-3 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 71335-0681-2 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 71335-0681-1 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 71335-0681-3 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 71335-0681-2 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 71335-0681-1 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 71335-0681-3 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 71335-0681-2 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 71335-0681-1 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 71335-0681-3 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 71335-0681-2 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 71335-0681-1 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 71335-0681-3 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 71335-0681-2 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 71335-0681-1 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 71335-0681-3 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 71335-0681-2 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 71335-0681-1 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 71335-0681-3 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product Y Unknown FDA exclusion code: Y 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 71335-0681-2 Y Unknown FDA exclusion code: Y 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 71335-0681-1 Y Unknown FDA exclusion code: Y 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A200751-001 ARMODAFINIL ARMODAFINIL 50MG TABLET / ORAL 2016-11-28 A200751-003 ARMODAFINIL ARMODAFINIL 150MG TABLET / ORAL 2016-11-28 A200751-004 ARMODAFINIL ARMODAFINIL 200MG TABLET / ORAL 2016-11-28 A200751-005 ARMODAFINIL ARMODAFINIL 250MG TABLET / ORAL 2016-11-28
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 5 · 168 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 2026-08-18 06:07:40 2026-07 A200751-001 ARMODAFINIL 50MG TABLET / ORAL 2016-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200751-003 ARMODAFINIL 150MG TABLET / ORAL 2016-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200751-004 ARMODAFINIL 200MG TABLET / ORAL 2016-11-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200751-005 ARMODAFINIL 250MG TABLET / ORAL 2016-11-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200751-001 ARMODAFINIL 50MG TABLET / ORAL AB 2016-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200751-003 ARMODAFINIL 150MG TABLET / ORAL AB 2016-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200751-004 ARMODAFINIL 200MG TABLET / ORAL AB 2016-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200751-005 ARMODAFINIL 250MG TABLET / ORAL AB 2016-11-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200751-001 ARMODAFINIL 50MG TABLET / ORAL AB 2016-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200751-003 ARMODAFINIL 150MG TABLET / ORAL AB 2016-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200751-004 ARMODAFINIL 200MG TABLET / ORAL AB 2016-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200751-005 ARMODAFINIL 250MG TABLET / ORAL AB 2016-11-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200751-001 ARMODAFINIL 50MG TABLET / ORAL AB 2016-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200751-003 ARMODAFINIL 150MG TABLET / ORAL AB 2016-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200751-004 ARMODAFINIL 200MG TABLET / ORAL AB 2016-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200751-005 ARMODAFINIL 250MG TABLET / ORAL AB 2016-11-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200751-001 ARMODAFINIL 50MG TABLET / ORAL AB 2016-11-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200751-003 ARMODAFINIL 150MG TABLET / ORAL AB 2016-11-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200751-004 ARMODAFINIL 200MG TABLET / ORAL AB 2016-11-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200751-005 ARMODAFINIL 250MG TABLET / ORAL AB 2016-11-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200751-001 ARMODAFINIL 50MG TABLET / ORAL AB 2016-11-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200751-003 ARMODAFINIL 150MG TABLET / ORAL AB 2016-11-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200751-004 ARMODAFINIL 200MG TABLET / ORAL AB 2016-11-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200751-005 ARMODAFINIL 250MG TABLET / ORAL AB 2016-11-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200751-001 ARMODAFINIL 50MG TABLET / ORAL AB 2016-11-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200751-003 ARMODAFINIL 150MG TABLET / ORAL AB 2016-11-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200751-004 ARMODAFINIL 200MG TABLET / ORAL AB 2016-11-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200751-005 ARMODAFINIL 250MG TABLET / ORAL AB 2016-11-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200751-001 ARMODAFINIL 50MG TABLET / ORAL AB 2016-11-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200751-003 ARMODAFINIL 150MG TABLET / ORAL AB 2016-11-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200751-004 ARMODAFINIL 200MG TABLET / ORAL AB 2016-11-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200751-005 ARMODAFINIL 250MG TABLET / ORAL AB 2016-11-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200751-001 ARMODAFINIL 50MG TABLET / ORAL AB 2016-11-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200751-003 ARMODAFINIL 150MG TABLET / ORAL AB 2016-11-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200751-004 ARMODAFINIL 200MG TABLET / ORAL AB 2016-11-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200751-005 ARMODAFINIL 250MG TABLET / ORAL AB 2016-11-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200751-001 ARMODAFINIL 50MG TABLET / ORAL AB 2016-11-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200751-003 ARMODAFINIL 150MG TABLET / ORAL AB 2016-11-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200751-004 ARMODAFINIL 200MG TABLET / ORAL AB 2016-11-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200751-005 ARMODAFINIL 250MG TABLET / ORAL AB 2016-11-28 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 160 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 71335-0681-1 2020-06-14 These highlights do not include all the information needed to use ARMODAFINIL TABLETS safely and effectively. See full prescribing information for ARMODAFINIL TABLETS. ARMODAFINIL Tablets, for oral use, C-IV Initial U.S. Approval: 2007 71335-0681-2 2020-06-14 These highlights do not include all the information needed to use ARMODAFINIL TABLETS safely and effectively. See full prescribing information for ARMODAFINIL TABLETS. ARMODAFINIL Tablets, for oral use, C-IV Initial U.S. Approval: 2007 71335-0681-3 2020-06-14 These highlights do not include all the information needed to use ARMODAFINIL TABLETS safely and effectively. See full prescribing information for ARMODAFINIL TABLETS. ARMODAFINIL Tablets, for oral use, C-IV Initial U.S. Approval: 2007 71335-0681-1 2020-01-31 These highlights do not include all the information needed to use ARMODAFINIL TABLETS safely and effectively. See full prescribing information for ARMODAFINIL TABLETS. ARMODAFINIL Tablets, for oral use, C-IV Initial U.S. Approval: 2007 71335-0681-2 2020-01-31 These highlights do not include all the information needed to use ARMODAFINIL TABLETS safely and effectively. See full prescribing information for ARMODAFINIL TABLETS. ARMODAFINIL Tablets, for oral use, C-IV Initial U.S. Approval: 2007 71335-0681-3 2020-01-31 These highlights do not include all the information needed to use ARMODAFINIL TABLETS safely and effectively. See full prescribing information for ARMODAFINIL TABLETS. ARMODAFINIL Tablets, for oral use, C-IV Initial U.S. Approval: 2007
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71335-0681-1 71335068101 30 TABLET in 1 BOTTLE (71335-0681-1) 30 tablet 2018-02-13 0000-00-00 No No Current 71335-0681-2 71335068102 28 TABLET in 1 BOTTLE (71335-0681-2) 28 tablet 2018-02-13 0000-00-00 No No Current 71335-0681-3 71335068103 90 TABLET in 1 BOTTLE (71335-0681-3) 90 tablet 2018-02-13 0000-00-00 No No Current