Application 078963

Type: ANDA
Sponsor: ORCHID HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MODAFINIL	MODAFINIL	TABLET;ORAL	100MG	No	No
002	MODAFINIL	MODAFINIL	TABLET;ORAL	200MG	No	No

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…`

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 ndc (product): 68788-8280
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 ndc (product): 69452-342 ndc (product): 69452-343

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42043-160	Modafinil	Modafinil	OrchidPharma Inc	ANDA	Current
42043-160	Modafinil	Modafinil	OrchidPharma Inc	ANDA	Current
42043-160	Modafinil	Modafinil	OrchidPharma Inc	ANDA	Current
42043-160	Modafinil	Modafinil	OrchidPharma Inc	ANDA	Current
42043-161	Modafinil	Modafinil	OrchidPharma Inc	ANDA	Current
42043-161	Modafinil	Modafinil	OrchidPharma Inc	ANDA	Current
42043-161	Modafinil	Modafinil	OrchidPharma Inc	ANDA	Current
42043-161	Modafinil	Modafinil	OrchidPharma Inc	ANDA	Current
50742-152	Modafinil	Modafinil	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-153	Modafinil	Modafinil	Ingenus Pharmaceuticals, LLC	ANDA	Current
55700-688	Modafinil	Modafinil	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
68071-2844	Modafinil	Modafinil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8079	Modafinil	Modafinil	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8079	Modafinil	Modafinil	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8280	Modafinil	Modafinil	Preferred Pharmaceuticals Inc.	ANDA	Current
69452-342	Modafinil	Modafinil	Bionpharma Inc.	ANDA	Current
69452-343	Modafinil	Modafinil	Bionpharma Inc.	ANDA	Current
71335-1402	Modafinil	Modafinil	Bryant Ranch Prepack	ANDA	Current
71335-1402	Modafinil	Modafinil	Bryant Ranch Prepack	ANDA	Current
71335-1793	Modafinil	Modafinil	Bryant Ranch Prepack	ANDA	Current
71335-1793	Modafinil	Modafinil	Bryant Ranch Prepack	ANDA	Current