Modafinil

Product NDC: 87063-308
11-digit product format: 870630308
Labeler code: 87063
Product ID: 87063-308_5b1b1793-3c64-3f34-e063-6294a90aa7ab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Modafinil
Dosage form: TABLET
Route: ORAL
Labeler: ASCLEMED USA INC.
Application: ANDA209966
Marketing category: ANDA
Marketing start: 2019-02-15
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: 2027-12-31
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
A209966-001	MODAFINIL	MODAFINIL	100MG	TABLET / ORAL	AB		2017-09-14
A209966-002	MODAFINIL	MODAFINIL	200MG	TABLET / ORAL	AB		2017-09-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209966-001	AB
A209966-002	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	A209966-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-09-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209966-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-09-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209966-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-09-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209966-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-09-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209966-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-09-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209966-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-09-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209966-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209966-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-09-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209966-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-09-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209966-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-09-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209966-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-09-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209966-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-09-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209966-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-09-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209966-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-09-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209966-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-09-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209966-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-09-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209966-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-09-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209966-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-09-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209966-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-09-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209966-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-09-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209966-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-09-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209966-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-09-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209966-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-09-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209966-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-09-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209966-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-09-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209966-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-09-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209966-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-09-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209966-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-09-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209966-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-09-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209966-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-09-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209966-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-09-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209966-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-09-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209966-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-09-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209966-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-09-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209966-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-09-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209966-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-09-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209966-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-09-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209966-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-09-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209966-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-09-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209966-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-09-14	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A209966-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209966-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209966-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209966-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209966-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209966-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209966-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209966-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209966-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209966-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209966-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209966-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209966-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209966-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209966-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209966-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209966-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209966-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209966-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209966-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209966-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209966-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209966-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209966-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209966-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209966-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209966-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209966-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209966-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209966-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209966-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209966-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209966-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209966-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209966-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209966-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209966-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209966-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209966-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209966-002	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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MODAFINIL	100 mg/1

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Modafinil	MODAFINIL	Aphena Pharma Solutions - Tennessee, LLC	4c9c4e61-517c-a9d2-e063-6394a90a58c7	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209966 application number: ANDA209966
Modafinil	MODAFINIL	Aphena Pharma Solutions - Tennessee, LLC	463bb960-a0b5-4ca4-e063-6294a90a683b	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209966 application number: ANDA209966
Modafinil	MODAFINIL	Golden State Medical Supply, Inc.	457662d8-b95c-d3af-e063-6294a90a883e	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209966 application number: ANDA209966
Modafinil	MODAFINIL	Aphena Pharma Solutions - Tennessee, LLC	2bc3cd03-2726-f693-e063-6294a90a7a03	2025-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209966 application number: ANDA209966
Modafinil	MODAFINIL	Zydus Lifesciences Limited	f39820fb-8248-4d42-854c-6fe2d9b92d36	2024-08-16		Exact identifier application applno (ANDA): 209966 application number: ANDA209966
Modafinil	MODAFINIL	Proficient Rx LP	c332ea93-48d9-4c8a-a1ef-01c27a61350b	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209966 application number: ANDA209966
Modafinil	MODAFINIL	Viona Pharmaceuticals Inc	15739a31-2433-49b5-90ea-b974214f73be	2023-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209966 application number: ANDA209966

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R3UK8X3U3D	MODAFINIL	68693-11-8	MODAFINIL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
87063-308-01	87063030801	100 TABLET in 1 BOTTLE (87063-308-01)	100 tablet	2026-09-10	No	No	Current
87063-308-30	87063030830	30 TABLET in 1 BOTTLE (87063-308-30)	30 tablet	2026-09-10	No	No	Current
87063-308-60	87063030860	60 TABLET in 1 BOTTLE (87063-308-60)	60 tablet	2026-09-10	No	No	Current
87063-308-90	87063030890	90 TABLET in 1 BOTTLE (87063-308-90)	90 tablet	2026-09-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Modafinil	ASCLEMED USA INC. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-09-10	HUMAN PRESCRIPTION DRUG LABEL	1