Primidone

Product NDC: 72888-160
Requested package NDC: 72888-160-05
11-digit product format: 728880160
Labeler code: 72888
Product ID: 72888-160_48453b30-812c-76c6-e063-6394a90ad9a0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Primidone
Dosage form: TABLET
Route: ORAL
Labeler: Advagen Pharma Limited
Application: ANDA214896
Marketing category: ANDA
Marketing start: 2022-06-28
Substance: PRIMIDONE
Active strength: 125 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 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214896-001	PRIMIDONE	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28
A214896-002	PRIMIDONE	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28
A214896-003	PRIMIDONE	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214896-001	AB
A214896-002	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	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214896-002	PRIMIDONE	250MG	TABLET / ORAL	AB	2022-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214896-003	PRIMIDONE	125MG	TABLET / ORAL		2022-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214896-001	PRIMIDONE	50MG	TABLET / ORAL	AB	2022-06-28	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 62 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A214896-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214896-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214896-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214896-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214896-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214896-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214896-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214896-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214896-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214896-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214896-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214896-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214896-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214896-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214896-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214896-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214896-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214896-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214896-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214896-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214896-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214896-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214896-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214896-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214896-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214896-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214896-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214896-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214896-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214896-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214896-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214896-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214896-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214896-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214896-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214896-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214896-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214896-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214896-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214896-002	AB	1	`a72a2bbeb626…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRIMIDONE	125 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
96304	Internal RxNorm lookup
198150	Internal RxNorm lookup
328176	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
b3b94d2e-6a64-45b7-b0cb-0fde689240d8	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
72888-160-00	Primidone	1000 in 1 BOTTLE	TABLET	1000	3
72888-160-01	Primidone	100 in 1 BOTTLE	TABLET	100	3
72888-160-05	Primidone	500 in 1 BOTTLE	TABLET	500	3
72888-160-30	Primidone	30 in 1 BOTTLE	TABLET	30	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72888-160	PRIMIDONE TABLET [ADVAGEN PHARMA LIMITED]	2	Current NDC, Legacy NDC, 4 package rows	20230112_b3b94d2e-6a64-45b7-b0cb-0fde689240d8.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Primidone	PRIMIDONE	Advagen Pharma Limited	b3b94d2e-6a64-45b7-b0cb-0fde689240d8	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214896 application number: ANDA214896 ndc (package): 72888-160-05 ndc (product): 72888-160 ndc11 (package): 72888016005
Primidone	PRIMIDONE	NorthStar Rx LLC	182a424b-d142-48c9-996b-059c0885f528	2025-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214896 application number: ANDA214896
Primidone	PRIMIDONE	TruPharma LLC.	c60b3a92-4404-4a89-b2c5-c23ff72bedad	2023-03-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214896 application number: ANDA214896

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
328176	primidone 125 MG Oral Tablet	PSN	b3b94d2e-6a64-45b7-b0cb-0fde689240d8	3
96304	primidone 250 MG Oral Tablet	PSN	b3b94d2e-6a64-45b7-b0cb-0fde689240d8	3
198150	primidone 50 MG Oral Tablet	PSN	b3b94d2e-6a64-45b7-b0cb-0fde689240d8	3
328176	primidone 125 MG Oral Tablet	SCD	b3b94d2e-6a64-45b7-b0cb-0fde689240d8	3
96304	primidone 250 MG Oral Tablet	SCD	b3b94d2e-6a64-45b7-b0cb-0fde689240d8	3
198150	primidone 50 MG Oral Tablet	SCD	b3b94d2e-6a64-45b7-b0cb-0fde689240d8	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72888-160-05	72888016005	500 TABLET in 1 BOTTLE (72888-160-05)	500 tablet	2022-06-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Primidone Tablets, USP 50 mg, 125 mg and 250 mg Rx only Anticonvulsant	Advagen Pharma Limited \| Rubicon Research Limited	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	3