Modafinil

Product NDC: 50090-4144
Requested package NDC: 50090-4144-0
11-digit product format: 500904144
Labeler code: 50090
Product ID: 50090-4144_f4ac9961-cccd-4838-8612-361b4084bafd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: modafinil
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA077667
Marketing category: ANDA
Marketing start: 2014-02-03
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-4144	50090-4144-0	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 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A077667-001	MODAFINIL	MODAFINIL	100MG	TABLET / ORAL	AB		2014-02-03
A077667-002	MODAFINIL	MODAFINIL	200MG	TABLET / ORAL	AB		2014-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077667-001	AB
A077667-002	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	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`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	A077667-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077667-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077667-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077667-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077667-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077667-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077667-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077667-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077667-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077667-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077667-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077667-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077667-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077667-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077667-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077667-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077667-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077667-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077667-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077667-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077667-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077667-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077667-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077667-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077667-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077667-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077667-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077667-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077667-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077667-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077667-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077667-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077667-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077667-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077667-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077667-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077667-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077667-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077667-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077667-002	AB	1	`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
50090-4144-0	2023-01-30	C162847	48780-1	f386c649-e681-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use MODAFINIL TABLETS, USP safely and effectively. See full prescribing information for MODAFINIL TABLETS, USP. MODAFINIL tablets, for oral use, C-IV Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-4144-0	Modafinil	30 in 1 BOTTLE	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4144	MODAFINIL TABLET [A-S MEDICATION SOLUTIONS]	1	Legacy NDC, 1 package rows	20190220_1b228142-f208-44fb-8abe-1adad707b89b.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Modafinil	MODAFINIL	Apotex Corp.	944daf47-49a6-93ca-e348-4a0f1b6d937e	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077667 application number: ANDA077667
Modafinil	MODAFINIL	Golden State Medical Supply, Inc.	1d4c6858-5b2f-f216-e063-6394a90aad5d	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077667 application number: ANDA077667
Modafinil	MODAFINIL	Major Pharmaceuticals	4a7ab52b-db31-4774-a06a-b11f2bb60662	2025-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077667 application number: ANDA077667
Modafinil	MODAFINIL	Aphena Pharma Solutions - Tennessee, LLC	a4a27496-0f5a-4ea8-b48c-72fcb323dc8f	2023-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077667 application number: ANDA077667

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	1b228142-f208-44fb-8abe-1adad707b89b	1
205324	modafinil 200 MG Oral Tablet	SCD	1b228142-f208-44fb-8abe-1adad707b89b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4144-0	50090414400	30 TABLET in 1 BOTTLE (50090-4144-0)	30 tablet	2019-02-14	0000-00-00	No	No	Current