Primidone

Product NDC: 10135-522
Requested package NDC: 10135-522-01
11-digit product format: 101350522
Labeler code: 10135
Product ID: 10135-522_ba71937b-a7fc-28c5-e053-2995a90a2000
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Primidone
Dosage form: TABLET
Route: ORAL
Labeler: Marlex Pharmaceuticals Inc
Application: ANDA084903
Marketing category: ANDA
Marketing start: 2015-05-01
Marketing end: 0000-00-00
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: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	10135-522	10135-522-01	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3a6e0ba9-1dda-c47a-a8e3-5844e445a4f8	Product name	3	20250114

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
10135-522-01	2023-01-30	Primidone
10135-522-05	2023-01-30	Primidone
10135-522-10	2023-01-30	Primidone
10135-522-01	2021-02-03	Primidone
10135-522-05	2021-02-03	Primidone
10135-522-10	2021-02-03	Primidone
10135-522-01	2021-01-29	Primidone
10135-522-05	2021-01-29	Primidone
10135-522-10	2021-01-29	Primidone

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10135-522-01	Primidone	100 in 1 BOTTLE	TABLET	100	3
10135-522-05	Primidone	500 in 1 BOTTLE	TABLET	500	3
10135-522-10	Primidone	1000 in 1 BOTTLE	TABLET	1000	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-522-01	EA - Each	10135-522	67ec3627-2281-42be-9982-2db5860bd766	1	2015-06-09
10135-522-05	EA - Each	10135-522	d117193a-d81f-47e3-85a7-dddea827f2ed	1	2015-06-09
10135-522-10	EA - Each	10135-522	195341d1-a2e6-40bc-ac15-88f51085aca6	1	2015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRIMIDONE	ACTIVE INGREDIENT	13AFD7670Q	PRIMIDONE TABLET [MARLEX PHARMACEUTICALS INC]	1
PRIMIDONE	ACTIVE MOIETY	13AFD7670Q	PRIMIDONE TABLET [MARLEX PHARMACEUTICALS INC]	1
ACACIA	INACTIVE INGREDIENT	5C5403N26O	PRIMIDONE TABLET [MARLEX PHARMACEUTICALS INC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PRIMIDONE TABLET [MARLEX PHARMACEUTICALS INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRIMIDONE TABLET [MARLEX PHARMACEUTICALS INC]	1
METHYLCELLULOSE (400 MPA.S)	INACTIVE INGREDIENT	O0GN6F9B2Y	PRIMIDONE TABLET [MARLEX PHARMACEUTICALS INC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PRIMIDONE TABLET [MARLEX PHARMACEUTICALS INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-522	PRIMIDONE TABLET [MARLEX PHARMACEUTICALS INC]	3	Legacy NDC, 3 package rows	20210204_934a6d96-6da2-4fba-bf1f-08e7acbf59bc.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
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	934a6d96-6da2-4fba-bf1f-08e7acbf59bc	3
198150	primidone 50 MG Oral Tablet	PSN	934a6d96-6da2-4fba-bf1f-08e7acbf59bc	3
96304	primidone 250 MG Oral Tablet	SCD	934a6d96-6da2-4fba-bf1f-08e7acbf59bc	3
198150	primidone 50 MG Oral Tablet	SCD	934a6d96-6da2-4fba-bf1f-08e7acbf59bc	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10135-522-01	10135052201	100 TABLET in 1 BOTTLE (10135-522-01)	100 tablet	2015-05-01	0000-00-00	No	No	Current