Primidone

Product NDC: 69584-684
11-digit product format: 695840684
Labeler code: 69584
Product ID: 69584-684_86b0848d-c247-4e50-bc01-dce7dc157605
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Primidone
Dosage form: TABLET
Route: ORAL
Labeler: Oxford Pharmaceuticals, LLC
Application: ANDA040586
Marketing category: ANDA
Marketing start: 2021-02-22
Substance: PRIMIDONE
Active strength: 50 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
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 · 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	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…`
2022-03-09 01:35 UTC	2022-03	A040586-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2005-02-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040586-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2005-02-24	`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	A040586-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040586-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040586-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040586-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040586-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040586-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040586-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040586-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040586-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040586-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040586-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040586-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040586-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040586-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040586-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040586-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040586-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040586-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040586-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040586-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040586-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040586-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040586-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040586-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040586-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040586-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040586-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040586-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040586-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040586-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040586-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040586-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040586-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040586-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040586-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040586-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040586-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040586-002	AB	1	`74a2ff9319b5…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Primidone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRIMIDONE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
13AFD7670Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
96304	Internal RxNorm lookup
198150	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
439096a4-c5d5-4ad8-be9c-238973a3e290	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3a6e0ba9-1dda-c47a-a8e3-5844e445a4f8	Product name	3	20250114
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69584-684-10	Primidone	100 in 1 BOTTLE, PLASTIC	TABLET	100		4
69584-684-50	Primidone	500 in 1 BOTTLE, PLASTIC	TABLET	500		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69584-684-10	EA - Each	69584-684	a9ad3ed0-49bf-45c7-b044-ff3e9326adf2	1	2021-03-02
69584-684-50	EA - Each	69584-684	1423b6cf-9c68-4d43-a5a8-23bc98d9dbcb	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69584-684	PRIMIDONE TABLET [OXFORD PHARMACEUTICALS, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20220407_439096a4-c5d5-4ad8-be9c-238973a3e290.zip

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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
PRIMIDONE	PRIMIDONE	DIRECT RX	c20f803c-e965-9dd8-e053-2995a90a92ba	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040586 application number: ANDA040586
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
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
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
13AFD7670Q	PRIMIDONE	125-33-7	PRIMIDONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198150	primidone 50 MG Oral Tablet	PSN	5067ff85-07f5-424c-b072-6907891e7b4e	103
198150	primidone 50 MG Oral Tablet	SCD	5067ff85-07f5-424c-b072-6907891e7b4e	103
96304	primidone 250 MG Oral Tablet	PSN	6046e4e9-0c1e-4d1f-85fa-d2ce25c5dc34	19
198150	primidone 50 MG Oral Tablet	PSN	6046e4e9-0c1e-4d1f-85fa-d2ce25c5dc34	19
96304	primidone 250 MG Oral Tablet	SCD	6046e4e9-0c1e-4d1f-85fa-d2ce25c5dc34	19
198150	primidone 50 MG Oral Tablet	SCD	6046e4e9-0c1e-4d1f-85fa-d2ce25c5dc34	19
96304	primidone 250 MG Oral Tablet	PSN	0193c0a4-f593-609c-e063-6294a90aaa68	9
198150	primidone 50 MG Oral Tablet	PSN	0193c0a4-f593-609c-e063-6294a90aaa68	9
96304	primidone 250 MG Oral Tablet	SCD	0193c0a4-f593-609c-e063-6294a90aaa68	9
198150	primidone 50 MG Oral Tablet	SCD	0193c0a4-f593-609c-e063-6294a90aaa68	9
96304	primidone 250 MG Oral Tablet	PSN	439096a4-c5d5-4ad8-be9c-238973a3e290	4
198150	primidone 50 MG Oral Tablet	PSN	439096a4-c5d5-4ad8-be9c-238973a3e290	4
96304	primidone 250 MG Oral Tablet	SCD	439096a4-c5d5-4ad8-be9c-238973a3e290	4
198150	primidone 50 MG Oral Tablet	SCD	439096a4-c5d5-4ad8-be9c-238973a3e290	4
198150	primidone 50 MG Oral Tablet	PSN	91de277e-34b8-4ee1-8846-f02aea626089	3
198150	primidone 50 MG Oral Tablet	SCD	91de277e-34b8-4ee1-8846-f02aea626089	3
198150	primidone 50 MG Oral Tablet	PSN	c20f803c-e965-9dd8-e053-2995a90a92ba	2
198150	primidone 50 MG Oral Tablet	SCD	c20f803c-e965-9dd8-e053-2995a90a92ba	2
96304	primidone 250 MG Oral Tablet	PSN	db761e34-8573-4f96-872c-e851b3004e5e	1
198150	primidone 50 MG Oral Tablet	PSN	db761e34-8573-4f96-872c-e851b3004e5e	1
96304	primidone 250 MG Oral Tablet	SCD	db761e34-8573-4f96-872c-e851b3004e5e	1
198150	primidone 50 MG Oral Tablet	SCD	db761e34-8573-4f96-872c-e851b3004e5e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69584-684-10	69584068410	100 TABLET in 1 BOTTLE, PLASTIC (69584-684-10)	100 tablet	2021-02-22	0000-00-00	No	No	Current
69584-684-50	69584068450	500 TABLET in 1 BOTTLE, PLASTIC (69584-684-50)	500 tablet	2021-02-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRIMIDONE TABLETS, USP 50 mg and 250 mg Anticonvulsant Rx only	Proficient Rx LP	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	1
PRIMIDONE TABLETS, USP 50 mg and 250 mg Anticonvulsant Rx only	PD-Rx Pharmaceuticals, Inc.	2025-10-20	HUMAN PRESCRIPTION DRUG LABEL	19
PRIMIDONE TABLETS, USP 50 mg and 250 mg Anticonvulsant Rx only	PD-Rx Pharmaceuticals, Inc.	2025-06-10	HUMAN PRESCRIPTION DRUG LABEL	9
PRIMIDONE	DIRECT RX	2025-01-17	HUMAN PRESCRIPTION DRUG LABEL	2
PRIMIDONE TABLETS, USP 50 mg and 250 mg Anticonvulsant Rx only	Bryant Ranch Prepack	2024-05-23	HUMAN PRESCRIPTION DRUG LABEL	103
PRIMIDONE TABLETS, USP 50 mg and 250 mg Anticonvulsant Rx only	Oxford Pharmaceuticals, LLC	2022-04-05	HUMAN PRESCRIPTION DRUG LABEL	4
PRIMIDONE TABLETS, USP 50 mg and 250 mg Anticonvulsant Rx Only	Aphena Pharma Solutions - Tennessee, LLC	2021-10-15	HUMAN PRESCRIPTION DRUG LABEL	3