Modafinil

Product NDC: 50742-152
11-digit product format: 507420152
Labeler code: 50742
Product ID: 50742-152_603ee70b-3373-48d8-9afb-8f0e66bf550b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Modafinil
Dosage form: TABLET
Route: ORAL
Labeler: Ingenus Pharmaceuticals, LLC
Application: ANDA078963
Marketing category: ANDA
Marketing start: 2014-04-01
Marketing end: 2019-12-31
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: 0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50742-152		D	Discontinued by firm	2026-08-07
excluded package	package	50742-152	50742-152-01	D	Discontinued by firm	2026-08-07
excluded package	package	50742-152	50742-152-30	D	Discontinued by firm	2026-08-07
excluded package	package	50742-152	50742-152-90	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 · 48 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	50742-152-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50742-152-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50742-152-30	`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	50742-152-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50742-152-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50742-152-30	`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	50742-152-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50742-152-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50742-152-30	`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	50742-152-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50742-152-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50742-152-30	`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	50742-152-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50742-152-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50742-152-30	`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	50742-152-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50742-152-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50742-152-30	`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	50742-152-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50742-152-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50742-152-30	`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	50742-152-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50742-152-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50742-152-30	`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	50742-152-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50742-152-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50742-152-30	`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	50742-152-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50742-152-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50742-152-30	`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	50742-152-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50742-152-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50742-152-30	`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	50742-152-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50742-152-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50742-152-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A078963-001	MODAFINIL	MODAFINIL	100MG	TABLET / ORAL	AB		2012-09-26
A078963-002	MODAFINIL	MODAFINIL	200MG	TABLET / ORAL	AB		2012-09-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078963-001	AB
A078963-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078963-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078963-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078963-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078963-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078963-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078963-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078963-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078963-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078963-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078963-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078963-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078963-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078963-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078963-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078963-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078963-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078963-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078963-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078963-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078963-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078963-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078963-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078963-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078963-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078963-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078963-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078963-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078963-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078963-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078963-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078963-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078963-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078963-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078963-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078963-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078963-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078963-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078963-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078963-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078963-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-26	`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	A078963-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078963-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078963-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078963-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078963-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078963-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078963-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078963-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078963-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078963-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078963-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078963-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078963-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078963-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078963-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078963-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078963-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078963-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078963-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078963-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078963-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078963-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078963-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078963-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078963-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078963-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078963-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078963-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078963-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078963-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078963-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078963-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078963-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078963-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078963-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078963-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078963-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078963-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078963-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078963-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50742-152-01	EA - Each	50742-152	12a4dc10-9fed-49a5-b245-42ee68d6a5f4	1	2014-05-02
50742-152-30	EA - Each	50742-152	f097cbb1-bfa2-4336-a9fc-07ffa061047e	1	2014-05-02
50742-152-90	EA - Each	50742-152	82f2ca76-2abd-4eef-9848-06f2a7b9cc87	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MODAFINIL	ACTIVE INGREDIENT	R3UK8X3U3D	MODAFINIL TABLET [INGENUS PHARMACEUTICALS, LLC]	2
MODAFINIL	ACTIVE MOIETY	R3UK8X3U3D	MODAFINIL TABLET [INGENUS PHARMACEUTICALS, LLC]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	MODAFINIL TABLET [INGENUS PHARMACEUTICALS, LLC]	2
colloidal silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	MODAFINIL TABLET [INGENUS PHARMACEUTICALS, LLC]	2
Crospovidone	INACTIVE INGREDIENT	68401960MK	MODAFINIL TABLET [INGENUS PHARMACEUTICALS, LLC]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	MODAFINIL TABLET [INGENUS PHARMACEUTICALS, LLC]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	MODAFINIL TABLET [INGENUS PHARMACEUTICALS, LLC]	2
povidone	INACTIVE INGREDIENT	FZ989GH94E	MODAFINIL TABLET [INGENUS PHARMACEUTICALS, LLC]	2
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	MODAFINIL TABLET [INGENUS PHARMACEUTICALS, LLC]	2
talc	INACTIVE INGREDIENT	7SEV7J4R1U	MODAFINIL TABLET [INGENUS PHARMACEUTICALS, LLC]	2

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Modafinil	MODAFINIL	Preferred Pharmaceuticals Inc.	013450dd-cd42-46c7-98d6-9a2925761978	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078963 application number: ANDA078963
Modafinil	MODAFINIL	Aphena Pharma Solutions - Tennessee, LLC	4aa3bdad-163f-fda1-e063-6394a90ae1d8	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078963 application number: ANDA078963
Modafinil	MODAFINIL	Bionpharma Inc.	63604fef-0b80-40ce-8dbf-3384f1aee395	2023-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078963 application number: ANDA078963

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Modafinil	Ingenus Pharmaceuticals, LLC \| Orchid Pharma Ltd. \| Orchid Helathcare (A Division of Orchid Pharma Ltd)	2018-10-12	HUMAN PRESCRIPTION DRUG LABEL	4