Modafinil

Product NDC: 57237-154
11-digit product format: 572370154
Labeler code: 57237
Product ID: 57237-154_2f270ddd-1b6f-40bf-bfdc-c3f47f716dd1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Modafinil
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA202566
Marketing category: ANDA
Marketing start: 2012-09-27
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: 2026-12-31
Current FDA listing: Yes

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
A202566-001	MODAFINIL	MODAFINIL	100MG	TABLET / ORAL	AB		2012-09-27
A202566-002	MODAFINIL	MODAFINIL	200MG	TABLET / ORAL	AB		2012-09-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202566-001	AB
A202566-002	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	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`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	A202566-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202566-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202566-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202566-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202566-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202566-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202566-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202566-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202566-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202566-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202566-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202566-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202566-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202566-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202566-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202566-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202566-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202566-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202566-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202566-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202566-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202566-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202566-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202566-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202566-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202566-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202566-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202566-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202566-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202566-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202566-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202566-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202566-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202566-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202566-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202566-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202566-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202566-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202566-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202566-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Modafinil
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MODAFINIL	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R3UK8X3U3D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
205324	Internal RxNorm lookup
260218	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4b63aac6-4385-44a3-8390-cdbb0b4b5fe0	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57237-154-01	Modafinil	100 in 1 BOTTLE	TABLET	100	6
57237-154-30	Modafinil	30 in 1 BOTTLE	TABLET	30	6
57237-154-90	Modafinil	90 in 1 BOTTLE	TABLET	90	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-154-30	EA - Each	57237-154	715285dc-e881-4f57-b340-474f0f4296a2	1	2016-01-13
57237-154-90	EA - Each	57237-154	2ef025cc-0270-4737-a0dc-d0b3decf06cc	1	2016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MODAFINIL	ACTIVE INGREDIENT	R3UK8X3U3D	MODAFINIL TABLET [CITRON PHARMA LLC]	1
MODAFINIL	ACTIVE MOIETY	R3UK8X3U3D	MODAFINIL TABLET [CITRON PHARMA LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MODAFINIL TABLET [CITRON PHARMA LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MODAFINIL TABLET [CITRON PHARMA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MODAFINIL TABLET [CITRON PHARMA LLC]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	MODAFINIL TABLET [CITRON PHARMA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-154	MODAFINIL TABLET [RISING PHARMA HOLDINGS, INC.]	6	Current NDC, Legacy NDC, 3 package rows	20240531_4b63aac6-4385-44a3-8390-cdbb0b4b5fe0.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Modafinil	MODAFINIL	AvPAK	4790bbe9-d753-1067-02ee-9536011650d9	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202566 application number: ANDA202566
Modafinil	MODAFINIL	American Health Packaging	928a3ab6-b53c-4924-882c-9f2f49aba0f1	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202566 application number: ANDA202566
Modafinil	MODAFINIL	Bryant Ranch Prepack	963aa6be-5aed-4865-b375-8c2c3102e7bc	2024-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202566 application number: ANDA202566
Modafinil	MODAFINIL	Bryant Ranch Prepack	f1ff7c6d-df04-48dd-a971-454d38e7d997	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202566 application number: ANDA202566
Modafinil	MODAFINIL	Bryant Ranch Prepack	f0c43046-fc86-4b62-bd0f-704a6894625d	2024-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202566 application number: ANDA202566
Modafinil	MODAFINIL	NuCare Pharmaceuticals,Inc.	98e54b10-8ae0-7c43-e053-2a95a90ae8bb	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202566 application number: ANDA202566
Modafinil	MODAFINIL	Rising Pharma Holdings, Inc.	4b63aac6-4385-44a3-8390-cdbb0b4b5fe0	2024-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202566 application number: ANDA202566 ndc (product): 57237-154
Modafinil	MODAFINIL	Aurobindo Pharma Limited	f51ca007-3955-4540-a88a-0ddae8d8e8ab	2024-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202566 application number: ANDA202566
Modafinil	MODAFINIL	Proficient Rx LP	d97684d7-c236-451e-99bd-b8df4bf36643	2023-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202566 application number: ANDA202566
Modafinil	MODAFINIL	Proficient Rx LP	ccf7836d-c131-4e7d-a339-fbf99fe7f449	2023-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202566 application number: ANDA202566

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	f1ff7c6d-df04-48dd-a971-454d38e7d997	8
260218	modafinil 100 MG Oral Tablet	SCD	f1ff7c6d-df04-48dd-a971-454d38e7d997	8
260218	modafinil 100 MG Oral Tablet	PSN	4b63aac6-4385-44a3-8390-cdbb0b4b5fe0	6
205324	modafinil 200 MG Oral Tablet	PSN	4b63aac6-4385-44a3-8390-cdbb0b4b5fe0	6
260218	modafinil 100 MG Oral Tablet	SCD	4b63aac6-4385-44a3-8390-cdbb0b4b5fe0	6
205324	modafinil 200 MG Oral Tablet	SCD	4b63aac6-4385-44a3-8390-cdbb0b4b5fe0	6
260218	modafinil 100 MG Oral Tablet	PSN	98e54b10-8ae0-7c43-e053-2a95a90ae8bb	3
260218	modafinil 100 MG Oral Tablet	SCD	98e54b10-8ae0-7c43-e053-2a95a90ae8bb	3
260218	modafinil 100 MG Oral Tablet	PSN	ccf7836d-c131-4e7d-a339-fbf99fe7f449	2
260218	modafinil 100 MG Oral Tablet	SCD	ccf7836d-c131-4e7d-a339-fbf99fe7f449	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57237-154-01	57237015401	100 TABLET in 1 BOTTLE (57237-154-01)	100 tablet	2012-09-27	0000-00-00	No	No	Current
57237-154-30	57237015430	30 TABLET in 1 BOTTLE (57237-154-30)	30 tablet	2012-09-27	0000-00-00	No	No	Current
57237-154-90	57237015490	90 TABLET in 1 BOTTLE (57237-154-90)	90 tablet	2012-09-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Modafinil	Bryant Ranch Prepack	2024-07-09	HUMAN PRESCRIPTION DRUG LABEL	8
Modafinil	NuCare Pharmaceuticals,Inc.	2024-06-20	HUMAN PRESCRIPTION DRUG LABEL	3
Modafinil	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2024-05-27	Human Prescription Drug Label	6
Modafinil	Proficient Rx LP	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	2