Provigil

Product NDC: 63459-101
11-digit product format: 634590101
Labeler code: 63459
Product ID: 63459-101_a505a386-c2a1-4a32-9523-b33b1528fb48
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Modafinil
Dosage form: TABLET
Route: ORAL
Labeler: Cephalon, LLC
Application: NDA020717
Marketing category: NDA
Marketing start: 1999-02-15
Marketing end: 2026-09-30
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
Current FDA listing: Yes

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
unfinished product	product	63459-101		UNFINISHED	Active or certified unfinished drug listing	2026-08-07
unfinished package	package	63459-101	63459-101-99	UNFINISHED	Active or certified unfinished drug listing	2026-08-07
excluded package	package	63459-101	63459-101-01	D	Discontinued by firm	2026-08-07

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 · 50 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	Archive	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	63459-101-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63459-101-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63459-101-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	63459-101-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	63459-101-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	63459-101-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63459-101-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63459-101-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63459-101-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63459-101-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	63459-101-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	63459-101-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63459-101-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	63459-101-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63459-101-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	63459-101-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63459-101-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	63459-101-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	63459-101-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63459-101-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	63459-101-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63459-101-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	63459-101-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63459-101-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	63459-101-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	63459-101-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	63459-101-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	63459-101-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	63459-101-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	63459-101-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	63459-101-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`

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
N020717-001	PROVIGIL	MODAFINIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24
N020717-002	PROVIGIL	MODAFINIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N020717-001	AB
N020717-002	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 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	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020717-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020717-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020717-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020717-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020717-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020717-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020717-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020717-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020717-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020717-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020717-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020717-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020717-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020717-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020717-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020717-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020717-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020717-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020717-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020717-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020717-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020717-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020717-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020717-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020717-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020717-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020717-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020717-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020717-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020717-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020717-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020717-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020717-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020717-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020717-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020717-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020717-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020717-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020717-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020717-002	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 118 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020717-001	7297346	2023-11-29	Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020717-002	7297346	2023-11-29	Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020717-001	7297346	2023-11-29	Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020717-002	7297346	2023-11-29	Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020717-001	7297346	2023-11-29	Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020717-002	7297346	2023-11-29	Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020717-001	7297346	2023-11-29	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020717-002	7297346	2023-11-29	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020717-001	7297346	2023-11-29	Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020717-002	7297346	2023-11-29	Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020717-001	7297346	2023-11-29	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Provigil

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MODAFINIL	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R3UK8X3U3D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
205324	Internal RxNorm lookup
213471	Internal RxNorm lookup
226426	Internal RxNorm lookup
260218	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e16c26ad-7bc2-d155-3a5d-da83ad6492c8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
91b7dea8-da1b-abb1-9750-2e680cd894b6	Product name	2	20171005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63459-101-01	Provigil	100 in 1 BOTTLE	TABLET	100		23
63459-101-30	Provigil	30 in 1 BOTTLE	TABLET	30		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63459-101-01	EA - Each	63459-101	1439a089-e7c4-4d87-ac25-6a11a9bee7cb	1	2012-07-24
63459-101-30	EA - Each	63459-101	d366ad0a-96de-410b-92da-7f68406a0cda	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MODAFINIL	ACTIVE INGREDIENT	R3UK8X3U3D	PROVIGIL (MODAFINIL) TABLET [CEPHALON, INCORPORATED]	7
MODAFINIL	ACTIVE MOIETY	R3UK8X3U3D	PROVIGIL (MODAFINIL) TABLET [CEPHALON, INCORPORATED]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROVIGIL (MODAFINIL) TABLET [CEPHALON, INCORPORATED]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PROVIGIL (MODAFINIL) TABLET [CEPHALON, INCORPORATED]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PROVIGIL (MODAFINIL) TABLET [CEPHALON, INCORPORATED]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROVIGIL (MODAFINIL) TABLET [CEPHALON, INCORPORATED]	7
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	PROVIGIL (MODAFINIL) TABLET [CEPHALON, INCORPORATED]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PROVIGIL (MODAFINIL) TABLET [CEPHALON, INCORPORATED]	7
MODAFINIL	ACTIVE INGREDIENT	R3UK8X3U3D	PROVIGIL (MODAFINIL) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
MODAFINIL	ACTIVE MOIETY	R3UK8X3U3D	PROVIGIL (MODAFINIL) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROVIGIL (MODAFINIL) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PROVIGIL (MODAFINIL) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PROVIGIL (MODAFINIL) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROVIGIL (MODAFINIL) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PROVIGIL (MODAFINIL) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PROVIGIL (MODAFINIL) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
MODAFINIL	ACTIVE INGREDIENT	R3UK8X3U3D	PROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]	1
MODAFINIL	ACTIVE MOIETY	R3UK8X3U3D	PROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	PROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63459-101	PROVIGIL (MODAFINIL) TABLET [CEPHALON, LLC]	23	Current NDC, Legacy NDC, 2 package rows	20250321_e16c26ad-7bc2-d155-3a5d-da83ad6492c8.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Provigil	MODAFINIL	Golden State Medical Supply, Inc.	3b8d1c32-dac9-50e6-e063-6394a90aa5a5	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020717 application number: NDA020717
Provigil	MODAFINIL	Apotex Corp	0391f182-1958-9fef-a944-53b229ce99e7	2025-08-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020717 application number: NDA020717
Modafinil	MODAFINIL	CIMA LABS INC.	9f3b0bd2-72a3-411f-aeec-b533373f1a97	2023-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020717 application number: NDA020717
Provigil	MODAFINIL	Cephalon, LLC	e16c26ad-7bc2-d155-3a5d-da83ad6492c8	2022-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020717 application number: NDA020717 ndc (product): 63459-101
modafinil	MODAFINIL	Aphena Pharma Solutions - Tennessee, LLC	cad4201c-133c-4a61-9d93-3c5e51695430	2017-12-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020717 application number: NDA020717

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R3UK8X3U3D	MODAFINIL	68693-11-8	MODAFINIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
260218	modafinil 100 MG Oral Tablet	PSN	e16c26ad-7bc2-d155-3a5d-da83ad6492c8	23
205324	modafinil 200 MG Oral Tablet	PSN	e16c26ad-7bc2-d155-3a5d-da83ad6492c8	23
226426	Provigil 100 MG Oral Tablet	PSN	e16c26ad-7bc2-d155-3a5d-da83ad6492c8	23
213471	Provigil 200 MG Oral Tablet	PSN	e16c26ad-7bc2-d155-3a5d-da83ad6492c8	23
226426	modafinil 100 MG Oral Tablet [Provigil]	SBD	e16c26ad-7bc2-d155-3a5d-da83ad6492c8	23
213471	modafinil 200 MG Oral Tablet [Provigil]	SBD	e16c26ad-7bc2-d155-3a5d-da83ad6492c8	23
260218	modafinil 100 MG Oral Tablet	SCD	e16c26ad-7bc2-d155-3a5d-da83ad6492c8	23
205324	modafinil 200 MG Oral Tablet	SCD	e16c26ad-7bc2-d155-3a5d-da83ad6492c8	23
226426	Provigil 100 MG Oral Tablet	SY	e16c26ad-7bc2-d155-3a5d-da83ad6492c8	23
213471	Provigil 200 MG Oral Tablet	SY	e16c26ad-7bc2-d155-3a5d-da83ad6492c8	23
260218	modafinil 100 MG Oral Tablet	PSN	5053c113-69df-4ade-a186-02bc054c23d1	2
205324	modafinil 200 MG Oral Tablet	PSN	5053c113-69df-4ade-a186-02bc054c23d1	2
226426	Provigil 100 MG Oral Tablet	PSN	5053c113-69df-4ade-a186-02bc054c23d1	2
213471	Provigil 200 MG Oral Tablet	PSN	5053c113-69df-4ade-a186-02bc054c23d1	2
226426	modafinil 100 MG Oral Tablet [Provigil]	SBD	5053c113-69df-4ade-a186-02bc054c23d1	2
213471	modafinil 200 MG Oral Tablet [Provigil]	SBD	5053c113-69df-4ade-a186-02bc054c23d1	2
260218	modafinil 100 MG Oral Tablet	SCD	5053c113-69df-4ade-a186-02bc054c23d1	2
205324	modafinil 200 MG Oral Tablet	SCD	5053c113-69df-4ade-a186-02bc054c23d1	2
226426	Provigil 100 MG Oral Tablet	SY	5053c113-69df-4ade-a186-02bc054c23d1	2
213471	Provigil 200 MG Oral Tablet	SY	5053c113-69df-4ade-a186-02bc054c23d1	2
260218	modafinil 100 MG Oral Tablet	PSN	8b79d52e-e6e5-4aaf-8835-242c72d6ee38	1
205324	modafinil 200 MG Oral Tablet	PSN	8b79d52e-e6e5-4aaf-8835-242c72d6ee38	1
226426	Provigil 100 MG Oral Tablet	PSN	8b79d52e-e6e5-4aaf-8835-242c72d6ee38	1
213471	Provigil 200 MG Oral Tablet	PSN	8b79d52e-e6e5-4aaf-8835-242c72d6ee38	1
226426	modafinil 100 MG Oral Tablet [Provigil]	SBD	8b79d52e-e6e5-4aaf-8835-242c72d6ee38	1
213471	modafinil 200 MG Oral Tablet [Provigil]	SBD	8b79d52e-e6e5-4aaf-8835-242c72d6ee38	1
260218	modafinil 100 MG Oral Tablet	SCD	8b79d52e-e6e5-4aaf-8835-242c72d6ee38	1
205324	modafinil 200 MG Oral Tablet	SCD	8b79d52e-e6e5-4aaf-8835-242c72d6ee38	1
226426	Provigil 100 MG Oral Tablet	SY	8b79d52e-e6e5-4aaf-8835-242c72d6ee38	1
213471	Provigil 200 MG Oral Tablet	SY	8b79d52e-e6e5-4aaf-8835-242c72d6ee38	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63459-101-01	63459010101	100 in 1 BOTTLE						Historical
63459-101-30	63459010130	30 TABLET in 1 BOTTLE (63459-101-30)	30 tablet	2011-01-03	2026-09-30	No	No	Current
63459-101-99	63459010199	40000 TABLET in 1 DRUM (63459-101-99)	40000 tablet	15-FEB-99				Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Provigil	Cephalon, LLC	2022-12-31	HUMAN PRESCRIPTION DRUG LABEL	23
PROVIGIL ® (modafinil) Tablets [C-IV]	Rebel Distributors Corp	2010-12-27	HUMAN PRESCRIPTION DRUG LABEL	1
PROVIGIL ® (modafinil) Tablets [C-IV]	Physicians Total Care, Inc.	2010-01-12	HUMAN PRESCRIPTION DRUG LABEL	2