Application 040586

Type: ANDA
Sponsor: OXFORD PHARMS

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 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
A040586-001	PRIMIDONE	PRIMIDONE	50MG	TABLET / ORAL	AB		2005-02-24
A040586-002	PRIMIDONE	PRIMIDONE	250MG	TABLET / ORAL	AB		2005-02-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040586-001	AB
A040586-002	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	A040586-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2005-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040586-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2005-02-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040586-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2005-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040586-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2005-02-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040586-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2005-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040586-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2005-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040586-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2005-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040586-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2005-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040586-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2005-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040586-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2005-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040586-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2005-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040586-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2005-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040586-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2005-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040586-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2005-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040586-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2005-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040586-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2005-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040586-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2005-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040586-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2005-02-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040586-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2005-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040586-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2005-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040586-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2005-02-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040586-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2005-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040586-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2005-02-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040586-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2005-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040586-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2005-02-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040586-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2005-02-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040586-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2005-02-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040586-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2005-02-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040586-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2005-02-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040586-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2005-02-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040586-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2005-02-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040586-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2005-02-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040586-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2005-02-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040586-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2005-02-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040586-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2005-02-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040586-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2005-02-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040586-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2005-02-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040586-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2005-02-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040586-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2005-02-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040586-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2005-02-24	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A040586-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040586-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040586-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040586-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040586-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040586-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040586-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040586-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040586-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040586-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040586-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040586-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040586-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040586-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040586-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040586-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040586-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040586-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040586-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040586-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040586-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A040586-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040586-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A040586-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040586-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040586-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040586-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040586-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040586-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040586-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040586-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040586-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040586-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A040586-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040586-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A040586-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040586-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040586-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040586-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A040586-002	AB	1	`f41ea6bd6efb…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Primidone	PRIMIDONE	NCS HealthCare of KY, LLC dba Vangard Labs	14f9aee1-4d3e-45e0-ad5c-70bd98667adc	2026-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040586 application number: ANDA040586
Primidone	PRIMIDONE	Proficient Rx LP	db761e34-8573-4f96-872c-e851b3004e5e	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040586 application number: ANDA040586
Primidone	PRIMIDONE	PD-Rx Pharmaceuticals, Inc.	6046e4e9-0c1e-4d1f-85fa-d2ce25c5dc34	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040586 application number: ANDA040586 ndc (product): 72789-177 ndc (product): 72789-178
Primidone	PRIMIDONE	PD-Rx Pharmaceuticals, Inc.	0193c0a4-f593-609c-e063-6294a90aaa68	2025-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040586 application number: ANDA040586 ndc (product): 72789-177 ndc (product): 72789-178
PRIMIDONE	PRIMIDONE	DIRECT RX	c20f803c-e965-9dd8-e053-2995a90a92ba	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040586 application number: ANDA040586 ndc (product): 72189-216
Primidone	PRIMIDONE	Bryant Ranch Prepack	5067ff85-07f5-424c-b072-6907891e7b4e	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040586 application number: ANDA040586 ndc (product): 71335-1965
Primidone	PRIMIDONE	Oxford Pharmaceuticals, LLC	439096a4-c5d5-4ad8-be9c-238973a3e290	2022-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040586 application number: ANDA040586 ndc (product): 69584-684 ndc (product): 69584-685
Primidone	PRIMIDONE	Aphena Pharma Solutions - Tennessee, LLC	91de277e-34b8-4ee1-8846-f02aea626089	2021-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040586 application number: ANDA040586 ndc (product): 71610-540
Primidone	PRIMIDONE	Aphena Pharma Solutions - Tennessee, LLC	70b93341-ce93-4be5-a782-87c1a26129d7	2021-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040586 application number: ANDA040586 ndc (product): 71610-590

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-5371	Primidone	primidone	Par Pharmaceutical	ANDA	Current
0603-5371	Primidone	primidone	Par Pharmaceutical	ANDA	Current
0603-5372	Primidone	primidone	Par Pharmaceutical	ANDA	Current
0603-5372	Primidone	primidone	Par Pharmaceutical	ANDA	Current
0615-7936	Primidone	primidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
42291-508	Primidone	primidone	AvKARE, Inc.	ANDA	Current
69584-684	Primidone	Primidone	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-684	Primidone	Primidone	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-685	Primidone	Primidone	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-685	Primidone	Primidone	Oxford Pharmaceuticals, LLC	ANDA	Current
71335-1965	Primidone	Primidone	Bryant Ranch Prepack	ANDA	Current
71335-1965	Primidone	Primidone	Bryant Ranch Prepack	ANDA	Current
71610-005	Primidone	primidone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-005	Primidone	primidone	Aphena Pharma Solutions -	ANDA	Current
71610-079	Primidone	primidone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-540	Primidone	Primidone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-540	Primidone	Primidone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-540	Primidone	Primidone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-590	Primidone	Primidone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72189-216	PRIMIDONE	PRIMIDONE	DIRECT RX	ANDA	Current
72789-177	Primidone	Primidone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-177	Primidone	Primidone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-177	Primidone	Primidone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-177	Primidone	Primidone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-177	Primidone	Primidone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-177	Primidone	Primidone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-178	Primidone	Primidone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-178	Primidone	Primidone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-178	Primidone	Primidone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-178	Primidone	Primidone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-178	Primidone	Primidone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-178	Primidone	Primidone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current