Home NDC 63629-7394 Modafinil
Product NDC 63629-7394
11-digit product format 636297394
Labeler code 63629
Product ID 63629-7394_088b1270-fe85-45f1-b1bb-595dbdb8126a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Modafinil
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA076715
Marketing category ANDA
Marketing start 2013-04-03
Marketing end 0000-00-00
Substance MODAFINIL
Active strength 100 mg/1
Pharmacologic classes Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]
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 2 · 70 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076715-001 MODAFINIL MODAFINIL 100MG TABLET / ORAL 2012-11-01 A076715-002 MODAFINIL MODAFINIL 200MG TABLET / ORAL 2012-11-01
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 3 · 82 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 A076715-001 MODAFINIL 100MG TABLET / ORAL 2012-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076715-002 MODAFINIL 200MG TABLET / ORAL 2012-11-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076715-001 MODAFINIL 100MG TABLET / ORAL 2012-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076715-002 MODAFINIL 200MG TABLET / ORAL 2012-11-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076715-001 MODAFINIL 100MG TABLET / ORAL 2012-11-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076715-002 MODAFINIL 200MG TABLET / ORAL 2012-11-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076715-001 MODAFINIL 100MG TABLET / ORAL AB 2012-11-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076715-002 MODAFINIL 200MG TABLET / ORAL AB 2012-11-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076715-001 MODAFINIL 100MG TABLET / ORAL AB 2012-11-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076715-002 MODAFINIL 200MG TABLET / ORAL AB 2012-11-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076715-001 MODAFINIL 100MG TABLET / ORAL AB 2012-11-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076715-002 MODAFINIL 200MG TABLET / ORAL AB 2012-11-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076715-001 MODAFINIL 100MG TABLET / ORAL AB 2012-11-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076715-002 MODAFINIL 200MG TABLET / ORAL AB 2012-11-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076715-001 MODAFINIL 100MG TABLET / ORAL AB 2012-11-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076715-002 MODAFINIL 200MG TABLET / ORAL AB 2012-11-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076715-001 MODAFINIL 100MG TABLET / ORAL AB 2012-11-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076715-002 MODAFINIL 200MG TABLET / ORAL AB 2012-11-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076715-001 MODAFINIL 100MG TABLET / ORAL AB 2012-11-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076715-002 MODAFINIL 200MG TABLET / ORAL AB 2012-11-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076715-001 MODAFINIL 100MG TABLET / ORAL AB 2012-11-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076715-002 MODAFINIL 200MG TABLET / ORAL AB 2012-11-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076715-001 MODAFINIL 100MG TABLET / ORAL AB 2012-11-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076715-002 MODAFINIL 200MG TABLET / ORAL AB 2012-11-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076715-001 MODAFINIL 100MG TABLET / ORAL AB 2012-11-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076715-002 MODAFINIL 200MG TABLET / ORAL AB 2012-11-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076715-001 MODAFINIL 100MG TABLET / ORAL AB 2012-11-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076715-002 MODAFINIL 200MG TABLET / ORAL AB 2012-11-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076715-001 MODAFINIL 100MG TABLET / ORAL AB 2012-11-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076715-002 MODAFINIL 200MG TABLET / ORAL AB 2012-11-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076715-001 MODAFINIL 100MG TABLET / ORAL AB 2012-11-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076715-002 MODAFINIL 200MG TABLET / ORAL AB 2012-11-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076715-001 MODAFINIL 100MG TABLET / ORAL AB 2012-11-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076715-002 MODAFINIL 200MG TABLET / ORAL AB 2012-11-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076715-001 MODAFINIL 100MG TABLET / ORAL AB 2012-11-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076715-002 MODAFINIL 200MG TABLET / ORAL AB 2012-11-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076715-001 MODAFINIL 100MG TABLET / ORAL AB 2012-11-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076715-002 MODAFINIL 200MG TABLET / ORAL AB 2012-11-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076715-001 MODAFINIL 100MG TABLET / ORAL AB 2012-11-01 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A076715-002 MODAFINIL 200MG TABLET / ORAL AB 2012-11-01 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-7394-1 2021-01-06 These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL t ablets for oral use, C-IV Initial U.S. Approval: 1998 63629-7394-2 2021-01-06 These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL t ablets for oral use, C-IV Initial U.S. Approval: 1998 63629-7394-3 2021-01-06 These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL t ablets for oral use, C-IV Initial U.S. Approval: 1998 63629-7394-4 2021-01-06 These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL t ablets for oral use, C-IV Initial U.S. Approval: 1998 63629-7394-1 2020-01-31 These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL t ablets for oral use, C-IV Initial U.S. Approval: 1998 63629-7394-2 2020-01-31 These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL t ablets for oral use, C-IV Initial U.S. Approval: 1998 63629-7394-3 2020-01-31 These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL t ablets for oral use, C-IV Initial U.S. Approval: 1998 63629-7394-4 2020-01-31 These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL t ablets for oral use, C-IV Initial U.S. Approval: 1998
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-7394-1 63629739401 30 TABLET in 1 BOTTLE (63629-7394-1) 30 tablet 2017-09-19 0000-00-00 No No Current 63629-7394-2 63629739402 60 TABLET in 1 BOTTLE (63629-7394-2) 60 tablet 2017-09-19 0000-00-00 No No Current 63629-7394-3 63629739403 28 TABLET in 1 BOTTLE (63629-7394-3) 28 tablet 2017-09-19 0000-00-00 No No Current 63629-7394-4 63629739404 90 TABLET in 1 BOTTLE (63629-7394-4) 90 tablet 2017-09-19 0000-00-00 No No Current