Modafinil

Product NDC: 63629-4998
Requested package NDC: 63629-4998-4
11-digit product format: 636294998
Labeler code: 63629
Product ID: 63629-4998_299a585f-fed1-49f2-8750-657b1c5e0c70
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Modafinil
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA202566
Marketing category: ANDA
Marketing start: 2012-09-27
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	63629-4998	63629-4998-4	D	Discontinued by firm		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, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`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
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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-4998-1	2024-07-24	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, CIV Initial U.S. Approval: 1998
63629-4998-2	2024-07-24	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, CIV Initial U.S. Approval: 1998
63629-4998-3	2024-07-24	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, CIV Initial U.S. Approval: 1998
63629-4998-4	2024-07-24	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, CIV Initial U.S. Approval: 1998
63629-4998-1	2024-01-30	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, CIV Initial U.S. Approval: 1998
63629-4998-2	2024-01-30	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, CIV Initial U.S. Approval: 1998
63629-4998-3	2024-01-30	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, CIV Initial U.S. Approval: 1998
63629-4998-4	2024-01-30	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, CIV Initial U.S. Approval: 1998
63629-4998-1	2022-02-16	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, CIV Initial U.S. Approval: 1998
63629-4998-2	2022-02-16	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, CIV Initial U.S. Approval: 1998
63629-4998-1	2020-01-31	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, CIV Initial U.S. Approval: 1998
63629-4998-2	2020-01-31	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, CIV Initial U.S. Approval: 1998

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MODAFINIL	ACTIVE INGREDIENT	R3UK8X3U3D	MODAFINIL TABLET [BRYANT RANCH PREPACK]	1001
MODAFINIL	ACTIVE MOIETY	R3UK8X3U3D	MODAFINIL TABLET [BRYANT RANCH PREPACK]	1001
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MODAFINIL TABLET [BRYANT RANCH PREPACK]	1001
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	MODAFINIL TABLET [BRYANT RANCH PREPACK]	1001
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MODAFINIL TABLET [BRYANT RANCH PREPACK]	1001
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MODAFINIL TABLET [BRYANT RANCH PREPACK]	1001
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MODAFINIL TABLET [BRYANT RANCH PREPACK]	1001
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MODAFINIL TABLET [BRYANT RANCH PREPACK]	1001
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	MODAFINIL TABLET [BRYANT RANCH PREPACK]	1001

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-4998-4	63629499804	18 TABLET in 1 BOTTLE (63629-4998-4)	18 tablet	2022-02-08	0000-00-00	No	No	Current