Primidone

Product NDC: 53746-545
11-digit product format: 537460545
Labeler code: 53746
Product ID: 53746-545_574c0bff-04c5-41f0-8d10-315a824d8efd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Primidone
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA040866
Marketing category: ANDA
Marketing start: 2009-12-24
Substance: PRIMIDONE
Active strength: 250 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Primidone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRIMIDONE	250 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
3cdc361a-5558-4341-ad40-f8bc29b4f1ce	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	SPL version
53746-545-01	Primidone	100 in 1 BOTTLE	TABLET	100	11
53746-545-05	Primidone	500 in 1 BOTTLE	TABLET	500	11
53746-545-10	Primidone	1000 in 1 BOTTLE	TABLET	1000	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53746-545-01	EA - Each	53746-545	73cddb18-bbe5-4c09-b4b6-7b19ca91d997	1	2017-09-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRIMIDONE	ACTIVE INGREDIENT	13AFD7670Q	PRIMIDONE TABLET [AVPAK]	8
PRIMIDONE	ACTIVE MOIETY	13AFD7670Q	PRIMIDONE TABLET [AVPAK]	8
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	PRIMIDONE TABLET [AVPAK]	8
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	PRIMIDONE TABLET [AVPAK]	8
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	PRIMIDONE TABLET [AVPAK]	8
Methylcellulose (100 Cps)	INACTIVE INGREDIENT	4GFU244C4J	PRIMIDONE TABLET [AVPAK]	8
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	PRIMIDONE TABLET [AVPAK]	8
Sodium Starch Glycolate Type A Potato	INACTIVE INGREDIENT	5856J3G2A2	PRIMIDONE TABLET [AVPAK]	8
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	PRIMIDONE TABLET [AVPAK]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53746-545	PRIMIDONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	10	Current NDC, Legacy NDC, 3 package rows	20240101_3cdc361a-5558-4341-ad40-f8bc29b4f1ce.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 · 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
Primidone	PRIMIDONE	AvKARE	e7a50a67-9653-463e-8c85-315b53f460c8	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040866 application number: ANDA040866
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): 53746-545
Primidone	PRIMIDONE	AvPAK	a90d5ba6-4170-0b97-5ae3-fc707c9e4f1b	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040866 application number: ANDA040866
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
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

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	a90d5ba6-4170-0b97-5ae3-fc707c9e4f1b	14
198150	primidone 50 MG Oral Tablet	PSN	a90d5ba6-4170-0b97-5ae3-fc707c9e4f1b	14
96304	primidone 250 MG Oral Tablet	SCD	a90d5ba6-4170-0b97-5ae3-fc707c9e4f1b	14
198150	primidone 50 MG Oral Tablet	SCD	a90d5ba6-4170-0b97-5ae3-fc707c9e4f1b	14
96304	primidone 250 MG Oral Tablet	PSN	3cdc361a-5558-4341-ad40-f8bc29b4f1ce	11
198150	primidone 50 MG Oral Tablet	PSN	3cdc361a-5558-4341-ad40-f8bc29b4f1ce	11
96304	primidone 250 MG Oral Tablet	SCD	3cdc361a-5558-4341-ad40-f8bc29b4f1ce	11
198150	primidone 50 MG Oral Tablet	SCD	3cdc361a-5558-4341-ad40-f8bc29b4f1ce	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53746-545-01	53746054501	100 TABLET in 1 BOTTLE (53746-545-01)	100 tablet	2009-12-24	0000-00-00	No	No	Current
53746-545-05	53746054505	500 TABLET in 1 BOTTLE (53746-545-05)	500 tablet	2009-12-24	0000-00-00	No	No	Current
53746-545-10	53746054510	1000 TABLET in 1 BOTTLE (53746-545-10)	1000 tablet	2009-12-24	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) Rx only	Amneal Pharmaceuticals of New York LLC	2026-04-02	HUMAN PRESCRIPTION DRUG LABEL	11
Primidone Tablets, USP Anticonvulsant Rx Only	AvPAK	2025-11-05	HUMAN PRESCRIPTION DRUG LABEL	14
Primidone Tablets, USP (50 mg and 250 mg) Rx only	A-S Medication Solutions	2023-02-06	HUMAN PRESCRIPTION DRUG LABEL	5