Modafinil

Product NDC: 0378-5575
11-digit product format: 003785575
Labeler code: 0378
Product ID: 0378-5575_f6947bbc-082d-48f6-ab5e-06610359865d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: modafinil
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA076594
Marketing category: ANDA
Marketing start: 2012-08-10
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: No
Listing certified through: 2020-12-31
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	0378-5575		D	Discontinued by firm	2026-08-07
excluded package	package	0378-5575	0378-5575-05	D	Discontinued by firm	2026-08-07
excluded package	package	0378-5575	0378-5575-93	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 · 36 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	0378-5575-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-5575-93	`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	0378-5575-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-5575-93	`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	0378-5575-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-5575-93	`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	0378-5575-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-5575-93	`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	0378-5575-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-5575-93	`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	0378-5575-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-5575-93	`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	0378-5575-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-5575-93	`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	0378-5575-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-5575-93	`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	0378-5575-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-5575-93	`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	0378-5575-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-5575-93	`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	0378-5575-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-5575-93	`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	0378-5575-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-5575-93	`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
A076594-001	MODAFINIL	MODAFINIL	100MG	TABLET / ORAL			2012-07-16
A076594-002	MODAFINIL	MODAFINIL	200MG	TABLET / ORAL			2012-07-16

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	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076594-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-07-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076594-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-07-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076594-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076594-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076594-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076594-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076594-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076594-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076594-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076594-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076594-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076594-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076594-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076594-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076594-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076594-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076594-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076594-002	AB	1	`ea99ee380514…`

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-5575-01	EA - Each	0378-5575	c1aa9f9a-3b66-4f85-a554-b2a0ea9a3399	1	2013-02-13
0378-5575-05	EA - Each	0378-5575	f12cf010-198e-40b0-b820-3eab9c75c678	1	2013-02-13
0378-5575-93	EA - Each	0378-5575	e79ed0aa-9321-4f3a-b19a-6a10905d27f0	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MODAFINIL	ACTIVE INGREDIENT	R3UK8X3U3D	MODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]	7
MODAFINIL	ACTIVE MOIETY	R3UK8X3U3D	MODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]	7
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	MODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]	7
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	MODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.]	7
MODAFINIL	ACTIVE INGREDIENT	R3UK8X3U3D	MODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]	3
MODAFINIL	ACTIVE MOIETY	R3UK8X3U3D	MODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]	3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	MODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	MODAFINIL TABLET [MYLAN INSTITUTIONAL INC.]	3
MODAFINIL	ACTIVE INGREDIENT	R3UK8X3U3D	MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
MODAFINIL	ACTIVE MOIETY	R3UK8X3U3D	MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	MODAFINIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1

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
205324	modafinil 200 MG Oral Tablet	PSN	514d242d-48c9-4162-a85a-a433b41107ac	1
205324	modafinil 200 MG Oral Tablet	SCD	514d242d-48c9-4162-a85a-a433b41107ac	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-5575-05	00378557505	500 TABLET in 1 BOTTLE, PLASTIC (0378-5575-05)	500 tablet	2012-08-10	0000-00-00	No	No	Current
0378-5575-93	00378557593	30 TABLET in 1 BOTTLE, PLASTIC (0378-5575-93)	30 tablet	2012-08-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Modafinil	Mylan Institutional Inc.	2019-11-07	HUMAN PRESCRIPTION DRUG LABEL	8
Modafinil	Preferred Pharmaceuticals Inc.	2019-10-31	HUMAN PRESCRIPTION DRUG LABEL	2
Modafinil	Mylan Pharmaceuticals Inc.	2016-03-17	HUMAN PRESCRIPTION DRUG LABEL	9
Modafinil - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2014-04-03	HUMAN PRESCRIPTION DRUG LABEL	1