Primidone

Product NDC: 71610-191
11-digit product format: 716100191
Labeler code: 71610
Product ID: 71610-191_5342e071-7b2f-4231-a73d-8c227f928494
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Primidone
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA084903
Marketing category: ANDA
Marketing start: 2005-04-07
Marketing end: 0000-00-00
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: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	71610-191		D	Discontinued by firm		2026-08-10
excluded package	package	71610-191	71610-191-60	D	Discontinued by firm		2026-08-10

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-191-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-191-60	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 82 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
2026-02-19 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…`
2021-12-28 21:50 UTC	2021-12	A084903-001	PRIMIDONE	250MG	TABLET / ORAL	AB	Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A084903-002	PRIMIDONE	50MG	TABLET / ORAL	AB		2001-05-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2021-12-28 21:50 UTC	2021-12	A084903-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A084903-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-191-60	EA - Each	71610-191	22562b5f-cd70-4e63-a1e2-9f25b34a75f7	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-191	PRIMIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC	20190109_fe761fa9-d97c-4ef4-a816-96e237c8749c.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-191-60	71610019160	90 TABLET in 1 BOTTLE (71610-191-60)	90 tablet	2018-11-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRIMIDONE TABLETS, USP	Aphena Pharma Solutions - Tennessee, LLC	2019-01-08	HUMAN PRESCRIPTION DRUG LABEL	2