Modafinil

Product NDC: 60505-2527
Requested package NDC: 60505-2527-1
11-digit product format: 605052527
Labeler code: 60505
Product ID: 60505-2527_e96ded7a-6c39-63d4-2029-f6db4dc3cd32
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: modafinil
Dosage form: TABLET
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA077667
Marketing category: ANDA
Marketing start: 2014-02-03
Marketing end: 2028-07-31
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
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 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
2026-09-14 22:38:34	2026-08	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077667-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077667-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077667-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077667-002	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Modafinil

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MODAFINIL	200 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
944daf47-49a6-93ca-e348-4a0f1b6d937e	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
60505-2527-0	Modafinil	10 in 1 BOX, UNIT-DOSE	TABLET	10	20
60505-2527-0	Modafinil	10 in 1 BLISTER PACK	TABLET	10	20
60505-2527-1	Modafinil	100 in 1 BOTTLE	TABLET	100	20
60505-2527-3	Modafinil	30 in 1 BOTTLE	TABLET	30	20
60505-2527-5	Modafinil	500 in 1 BOTTLE	TABLET	500	20
60505-2527-8	Modafinil	1000 in 1 BOTTLE	TABLET	1000	20
60505-2527-9	Modafinil	90 in 1 BOTTLE	TABLET	90	20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MODAFINIL	ACTIVE INGREDIENT	R3UK8X3U3D	MODAFINIL TABLET [APOTEX CORP.]	10
MODAFINIL	ACTIVE MOIETY	R3UK8X3U3D	MODAFINIL TABLET [APOTEX CORP.]	10
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MODAFINIL TABLET [APOTEX CORP.]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MODAFINIL TABLET [APOTEX CORP.]	10
METHYLCELLULOSE (15 CPS)	INACTIVE INGREDIENT	NPU9M2E6L8	MODAFINIL TABLET [APOTEX CORP.]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MODAFINIL TABLET [APOTEX CORP.]	10
MODAFINIL	ACTIVE INGREDIENT	R3UK8X3U3D	MODAFINIL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
MODAFINIL	ACTIVE MOIETY	R3UK8X3U3D	MODAFINIL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MODAFINIL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MODAFINIL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
METHYLCELLULOSE (15 MPA.S)	INACTIVE INGREDIENT	NPU9M2E6L8	MODAFINIL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MODAFINIL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-2527	MODAFINIL TABLET [APOTEX CORP.]	19	Current NDC, Legacy NDC, 7 package rows	20240606_944daf47-49a6-93ca-e348-4a0f1b6d937e.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 ndc (package): 60505-2527-1 ndc (product): 60505-2527 ndc11 (package): 60505252701
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
260218	modafinil 100 MG Oral Tablet	PSN	944daf47-49a6-93ca-e348-4a0f1b6d937e	20
205324	modafinil 200 MG Oral Tablet	PSN	944daf47-49a6-93ca-e348-4a0f1b6d937e	20
260218	modafinil 100 MG Oral Tablet	SCD	944daf47-49a6-93ca-e348-4a0f1b6d937e	20
205324	modafinil 200 MG Oral Tablet	SCD	944daf47-49a6-93ca-e348-4a0f1b6d937e	20
260218	modafinil 100 MG Oral Tablet	PSN	4a7ab52b-db31-4774-a06a-b11f2bb60662	4
205324	modafinil 200 MG Oral Tablet	PSN	4a7ab52b-db31-4774-a06a-b11f2bb60662	4
260218	modafinil 100 MG Oral Tablet	SCD	4a7ab52b-db31-4774-a06a-b11f2bb60662	4
205324	modafinil 200 MG Oral Tablet	SCD	4a7ab52b-db31-4774-a06a-b11f2bb60662	4
205324	modafinil 200 MG Oral Tablet	PSN	a4a27496-0f5a-4ea8-b48c-72fcb323dc8f	2
205324	modafinil 200 MG Oral Tablet	SCD	a4a27496-0f5a-4ea8-b48c-72fcb323dc8f	2
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
60505-2527-1	60505252701	100 TABLET in 1 BOTTLE (60505-2527-1)	100 tablet	2021-01-14	2027-02-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Modafinil	Apotex Corp. \| Apotex Inc	2026-07-21	HUMAN PRESCRIPTION DRUG LABEL	21
Modafinil	Major Pharmaceuticals	2025-03-11	HUMAN PRESCRIPTION DRUG LABEL	4
Modafinil	Aphena Pharma Solutions - Tennessee, LLC	2023-01-16	HUMAN PRESCRIPTION DRUG LABEL	2
Modafinil	Quality Care Products, LLC	2021-04-16	HUMAN PRESCRIPTION DRUG LABEL	3
Modafinil	Golden State Medical Supply, Inc.	2020-01-27	HUMAN PRESCRIPTION DRUG LABEL	5
Modafinil	A-S Medication Solutions	2019-02-18	HUMAN PRESCRIPTION DRUG LABEL	1
Modafinil	Bryant Ranch Prepack	2018-10-08	HUMAN PRESCRIPTION DRUG LABEL	3