Primidone

Product NDC: 51407-637
11-digit product format: 514070637
Labeler code: 51407
Product ID: 51407-637_29f49f7f-d100-e0e1-e063-6394a90ac981
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Primidone
Dosage form: TABLET
Route: ORAL
Labeler: Golden State Medical Supply, Inc
Application: ANDA084903
Marketing category: ANDA
Marketing start: 2001-05-24
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
A084903-001	PRIMIDONE	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982
A084903-002	PRIMIDONE	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A084903-001	AB
A084903-002	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`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	A084903-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A084903-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084903-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084903-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084903-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084903-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084903-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084903-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084903-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084903-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084903-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084903-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084903-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084903-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084903-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084903-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084903-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084903-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084903-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084903-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084903-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A084903-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084903-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084903-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084903-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084903-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084903-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084903-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084903-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A084903-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084903-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084903-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084903-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A084903-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084903-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A084903-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084903-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A084903-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084903-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A084903-002	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
e4e493bd-94d7-7e5a-e053-2995a90a2706	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51407-637-01	Primidone	100 in 1 BOTTLE	TABLET	100		2
51407-637-05	Primidone	500 in 1 BOTTLE	TABLET	500		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51407-637-01	EA - Each	51407-637	b61c12fb-15e3-43b5-b231-cb9b6fbe4a7f	1	2022-09-12
51407-637-05	EA - Each	51407-637	d521ba4e-d64d-42bd-8ad1-116e4f841b8f	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51407-637	PRIMIDONE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC]	2	Current NDC, Legacy NDC, 2 package rows	20241228_e4e493bd-94d7-7e5a-e053-2995a90a2706.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Primidone	PRIMIDONE	Chartwell RX, LLC	4a8e309f-d89e-4b1a-abb2-856a66ebbff9	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084903 application number: ANDA084903
Primidone	PRIMIDONE	Golden State Medical Supply, Inc	e4e493bd-94d7-7e5a-e053-2995a90a2706	2024-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084903 application number: ANDA084903 ndc (product): 51407-637
Primidone	PRIMIDONE	American Health Packaging	a32e0a00-3ba7-47e7-83c6-a7eac5fbdd11	2024-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084903 application number: ANDA084903
Primidone	PRIMIDONE	Aphena Pharma Solutions - Tennessee, LLC	ad8b50e2-e797-4326-a57e-d254da85b6b9	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084903 application number: ANDA084903
Primidone	PRIMIDONE	Lannett Company, Inc.	a1a817f7-c190-4825-94eb-442f477187e3	2020-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084903 application number: ANDA084903

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
96304	primidone 250 MG Oral Tablet	PSN	e4e493bd-94d7-7e5a-e053-2995a90a2706	2
198150	primidone 50 MG Oral Tablet	PSN	ad8b50e2-e797-4326-a57e-d254da85b6b9	2
198150	primidone 50 MG Oral Tablet	PSN	e4e493bd-94d7-7e5a-e053-2995a90a2706	2
96304	primidone 250 MG Oral Tablet	SCD	e4e493bd-94d7-7e5a-e053-2995a90a2706	2
198150	primidone 50 MG Oral Tablet	SCD	ad8b50e2-e797-4326-a57e-d254da85b6b9	2
198150	primidone 50 MG Oral Tablet	SCD	e4e493bd-94d7-7e5a-e053-2995a90a2706	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51407-637-01	51407063701	100 TABLET in 1 BOTTLE (51407-637-01)	100 tablet	2022-02-03	0000-00-00	No	No	Current
51407-637-05	51407063705	500 TABLET in 1 BOTTLE (51407-637-05)	500 tablet	2022-02-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Primidone Tablets, USP	Golden State Medical Supply, Inc \| Golden State Medical Supply, Inc.	2024-12-23	HUMAN PRESCRIPTION DRUG LABEL	2
Primidone Tablets, USP	Aphena Pharma Solutions - Tennessee, LLC	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	2