Modafinil

Product NDC: 68071-2844
Requested package NDC: 68071-2844-3
11-digit product format: 680712844
Labeler code: 68071
Product ID: 68071-2844_ea3e248d-a47f-74d7-e053-2a95a90add6e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Modafinil
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA078963
Marketing category: ANDA
Marketing start: 2022-02-28
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: 2023-12-31
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	68071-2844	68071-2844-3	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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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 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
68071-2844-3	2025-01-30	C162847	48780-1	2cef2736-ac95-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. 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
68071-2844-3	Modafinil	1 in 1 CARTON	TABLET	1		1
68071-2844-3	Modafinil	3 in 1 BOTTLE, PLASTIC	TABLET	3		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2844	MODAFINIL TABLET [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 2 package rows	20221005_ea3decc2-a34e-13d6-e053-2995a90a7b5d.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
205324	modafinil 200 MG Oral Tablet	PSN	ea3decc2-a34e-13d6-e053-2995a90a7b5d	1
205324	modafinil 200 MG Oral Tablet	SCD	ea3decc2-a34e-13d6-e053-2995a90a7b5d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2844-3	68071284403	1 BOTTLE, PLASTIC in 1 CARTON (68071-2844-3) > 3 TABLET in 1 BOTTLE, PLASTIC	2022-10-04	0000-00-00	No	No	Current