PROVIGIL

Product NDC: 21695-235
11-digit product format: 216950235
Labeler code: 21695
Product ID: 21695-235_8b79d52e-e6e5-4aaf-8835-242c72d6ee38
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MODAFINIL
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA020717
Marketing category: NDA
Marketing start: 2004-01-19
Marketing end: 0000-00-00
Substance: MODAFINIL
Active strength: 200 mg/1
Pharmacologic classes: Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]
DEA schedule: CIV
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-235		I	Inactivated by FDA	2026-08-07
excluded package	package	21695-235	21695-235-15	I	Inactivated by FDA	2026-08-07
excluded package	package	21695-235	21695-235-30	I	Inactivated by FDA	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 2 · 66 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	21695-235-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-235-30	`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	21695-235-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-235-30	`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	21695-235-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-235-30	`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	21695-235-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-235-30	`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	21695-235-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-235-30	`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	21695-235-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-235-30	`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	21695-235-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-235-30	`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	21695-235-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-235-30	`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	21695-235-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-235-30	`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	21695-235-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-235-30	`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	21695-235-15	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-235-30	`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	21695-235-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-235-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-235-15	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-235-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-235-15	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-235-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-235-15	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-235-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-235-15	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-235-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-235-15	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-235-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-235-15	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-235-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-235-15	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-235-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-235-15	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-235-30	`e2bbac7714bc…`	`27bdfed8d636…`

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…`

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-235-15	2019-09-24	C162847	48780-1	934fe258-4a94-48b1-e053-8cdaa90a720a	PROVIGIL ® (modafinil) Tablets [C-IV]
21695-235-30	2019-09-24	C162847	48780-1	934fe258-4a94-48b1-e053-8cdaa90a720a	PROVIGIL ® (modafinil) Tablets [C-IV]

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-235-15	PROVIGIL	15 in 1 BOTTLE	TABLET	15		1
21695-235-30	PROVIGIL	30 in 1 BOTTLE	TABLET	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-235-15	EA - Each	21695-235	d7c1a9a8-b42a-4d77-a766-90c9d8ebc415	1	2012-07-24
21695-235-30	EA - Each	21695-235	ba834484-5a81-4bf6-96f7-3f4efbb013f3	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 [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
21695-235	PROVIGIL (MODAFINIL) TABLET [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20110104_8b79d52e-e6e5-4aaf-8835-242c72d6ee38.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
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	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	Status
21695-235-15	21695023515	15 in 1 BOTTLE	Historical
21695-235-30	21695023530	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROVIGIL ® (modafinil) Tablets [C-IV]	Rebel Distributors Corp	2010-12-27	HUMAN PRESCRIPTION DRUG LABEL	1