Application 040866

Type: ANDA
Sponsor: AMNEAL PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRIMIDONE	PRIMIDONE	TABLET;ORAL	50MG	No	No
002	PRIMIDONE	PRIMIDONE	TABLET;ORAL	250MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A040866-001	PRIMIDONE	PRIMIDONE	50MG	TABLET / ORAL	AB		2008-04-23
A040866-002	PRIMIDONE	PRIMIDONE	250MG	TABLET / ORAL	AB		2008-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040866-001	AB
A040866-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A040866-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2008-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040866-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2008-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040866-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2008-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040866-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2008-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040866-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2008-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040866-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2008-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040866-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2008-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040866-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2008-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040866-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2008-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040866-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2008-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040866-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2008-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040866-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2008-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040866-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2008-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040866-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2008-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040866-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2008-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040866-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2008-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040866-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2008-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040866-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2008-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040866-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2008-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040866-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2008-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040866-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2008-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040866-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2008-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040866-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2008-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040866-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2008-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040866-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2008-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040866-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2008-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040866-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2008-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040866-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2008-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040866-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2008-04-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040866-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2008-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040866-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2008-04-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040866-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2008-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040866-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2008-04-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040866-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2008-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040866-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2008-04-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040866-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2008-04-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040866-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2008-04-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040866-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2008-04-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040866-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2008-04-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040866-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2008-04-23	`bb7c543d1eb4…`

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
2026-08-18 06:07:40	2026-07	A040866-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040866-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040866-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040866-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040866-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040866-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040866-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040866-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040866-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040866-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040866-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040866-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040866-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040866-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040866-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040866-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040866-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040866-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040866-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040866-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040866-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040866-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040866-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040866-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040866-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040866-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040866-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040866-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040866-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040866-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040866-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040866-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040866-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040866-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040866-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040866-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040866-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040866-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040866-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040866-002	AB	1	`bb7c543d1eb4…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Primidone	PRIMIDONE	Bryant Ranch Prepack	93b4b34c-6dba-4aec-b98e-b2b18feb86a9	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040866 application number: ANDA040866 ndc (product): 63629-7811
Primidone	PRIMIDONE	AvKARE	e7a50a67-9653-463e-8c85-315b53f460c8	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040866 application number: ANDA040866 ndc (product): 42291-509 ndc (product): 42291-511
Primidone	PRIMIDONE	Amneal Pharmaceuticals of New York LLC	3cdc361a-5558-4341-ad40-f8bc29b4f1ce	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040866 application number: ANDA040866 ndc (product): 53746-544 ndc (product): 53746-545
Primidone	PRIMIDONE	AvPAK	a90d5ba6-4170-0b97-5ae3-fc707c9e4f1b	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040866 application number: ANDA040866 ndc (product): 50268-687 ndc (product): 50268-686
Primidone	PRIMIDONE	Amneal Pharmaceuticals LLC	02ba0182-0870-4c0d-a814-a1dc427d47b8	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040866 application number: ANDA040866 ndc (product): 65162-544 ndc (product): 65162-545
Primidone	PRIMIDONE	NCS HealthCare of KY, LLC dba Vangard Labs	1c56d09c-4224-4875-bb22-e8bfd595d378	2023-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040866 application number: ANDA040866 ndc (product): 0615-8206

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8206	Primidone	Primidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
42291-509	Primidone	Primidone	AvKARE	ANDA	Current
42291-511	Primidone	Primidone	AvKARE, Inc.	ANDA	Current
42291-511	Primidone	Primidone	AvKARE	ANDA	Current
50090-1636	Primidone	Primidone	A-S Medication Solutions	ANDA	Current
50090-1636	Primidone	Primidone	A-S Medication Solutions	ANDA	Current
50090-4083	Primidone	Primidone	A-S Medication Solutions	ANDA	Current
50090-4083	Primidone	Primidone	A-S Medication Solutions	ANDA	Current
50268-686	Primidone	Primidone	AvPAK	ANDA	Current
50268-686	Primidone	Primidone	AvPAK	ANDA	Current
50268-687	Primidone	Primidone	AvPAK	ANDA	Current
50268-687	Primidone	Primidone	AvPAK	ANDA	Current
53746-544	Primidone	Primidone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-544	Primidone	Primidone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-544	Primidone	Primidone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-544	Primidone	Primidone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-544	Primidone	Primidone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-544	Primidone	Primidone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-544	Primidone	Primidone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-545	Primidone	Primidone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-545	Primidone	Primidone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-545	Primidone	Primidone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-545	Primidone	Primidone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-545	Primidone	Primidone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-545	Primidone	Primidone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-545	Primidone	Primidone	Amneal Pharmaceuticals of New York LLC	ANDA	Current
63629-7811	Primidone	Primidone	Bryant Ranch Prepack	ANDA	Current
63629-7811	Primidone	Primidone	Bryant Ranch Prepack	ANDA	Current
63629-7811	Primidone	Primidone	Bryant Ranch Prepack	ANDA	Current
65162-544	Primidone	Primidone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-544	Primidone	Primidone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-544	Primidone	Primidone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-544	Primidone	Primidone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-544	Primidone	Primidone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-545	Primidone	Primidone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-545	Primidone	Primidone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-545	Primidone	Primidone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-545	Primidone	Primidone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-545	Primidone	Primidone	Amneal Pharmaceuticals LLC	ANDA	Current