Primidone

Product NDC: 0527-1231
11-digit product format: 005271231
Labeler code: 0527
Product ID: 0527-1231_99bd0a67-2742-43dd-9ddc-430b9141c3b1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Primidone
Dosage form: TABLET
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA084903
Marketing category: ANDA
Marketing start: 1978-12-01
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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Primidone
Listing expiration: 2026-12-31

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
a1a817f7-c190-4825-94eb-442f477187e3	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0527-1231-01	2024-01-30	C162847	48780-1	1030e365-2f3e-111a-e063-dadaa90a10e2	Primidone Tablets, USP
0527-1231-05	2024-01-30	C162847	48780-1	1030e365-2f3e-111a-e063-dadaa90a10e2	Primidone Tablets, USP
0527-1231-10	2024-01-30	C162847	48780-1	1030e365-2f3e-111a-e063-dadaa90a10e2	Primidone Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0527-1231-01	Primidone	100 in 1 BOTTLE	TABLET	100	14
0527-1231-05	Primidone	500 in 1 BOTTLE	TABLET	500	14
0527-1231-10	Primidone	1000 in 1 BOTTLE	TABLET	1000	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-1231-01	EA - Each	0527-1231	14a1d6aa-62d1-4118-9797-8aa014294609	1	2012-07-24
0527-1231-10	EA - Each	0527-1231	6b5475ae-dcc0-4f12-8f41-6eb9f32f33c9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRIMIDONE	ACTIVE INGREDIENT	13AFD7670Q	PRIMIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]	9
PRIMIDONE	ACTIVE MOIETY	13AFD7670Q	PRIMIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]	9
ACACIA	INACTIVE INGREDIENT	5C5403N26O	PRIMIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]	9
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PRIMIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRIMIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]	9
METHYLCELLULOSE (400 CPS)	INACTIVE INGREDIENT	O0GN6F9B2Y	PRIMIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]	9
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PRIMIDONE TABLET [PHYSICIANS TOTAL CARE, INC.]	9
PRIMIDONE	ACTIVE INGREDIENT	13AFD7670Q	PRIMIDONE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
PRIMIDONE	ACTIVE INGREDIENT	13AFD7670Q	PRIMIDONE TABLET [LANNETT COMPANY, INC.]	6
PRIMIDONE	ACTIVE MOIETY	13AFD7670Q	PRIMIDONE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
PRIMIDONE	ACTIVE MOIETY	13AFD7670Q	PRIMIDONE TABLET [LANNETT COMPANY, INC.]	6
ACACIA	INACTIVE INGREDIENT	5C5403N26O	PRIMIDONE TABLET [LANNETT COMPANY, INC.]	6
ACACIA	INACTIVE INGREDIENT	5C5403N26O	PRIMIDONE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PRIMIDONE TABLET [LANNETT COMPANY, INC.]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PRIMIDONE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRIMIDONE TABLET [LANNETT COMPANY, INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRIMIDONE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
METHYLCELLULOSE (400 CPS)	INACTIVE INGREDIENT	O0GN6F9B2Y	PRIMIDONE TABLET [LANNETT COMPANY, INC.]	6
METHYLCELLULOSE (400 MPA.S)	INACTIVE INGREDIENT	O0GN6F9B2Y	PRIMIDONE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PRIMIDONE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PRIMIDONE TABLET [LANNETT COMPANY, INC.]	6
PRIMIDONE	ACTIVE INGREDIENT	13AFD7670Q	PRIMIDONE TABLET [AMERICAN HEALTH PACKAGING]	2
PRIMIDONE	ACTIVE MOIETY	13AFD7670Q	PRIMIDONE TABLET [AMERICAN HEALTH PACKAGING]	2
ACACIA	INACTIVE INGREDIENT	5C5403N26O	PRIMIDONE TABLET [AMERICAN HEALTH PACKAGING]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PRIMIDONE TABLET [AMERICAN HEALTH PACKAGING]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRIMIDONE TABLET [AMERICAN HEALTH PACKAGING]	2
METHYLCELLULOSE (400 MPA.S)	INACTIVE INGREDIENT	O0GN6F9B2Y	PRIMIDONE TABLET [AMERICAN HEALTH PACKAGING]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PRIMIDONE TABLET [AMERICAN HEALTH PACKAGING]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0527-1231	PRIMIDONE TABLET [LANNETT COMPANY, INC.]	14	Current NDC, Legacy NDC, 3 package rows	20240704_a1a817f7-c190-4825-94eb-442f477187e3.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 ndc (product): 0527-1231

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	a1a817f7-c190-4825-94eb-442f477187e3	14
198150	primidone 50 MG Oral Tablet	PSN	a1a817f7-c190-4825-94eb-442f477187e3	14
96304	primidone 250 MG Oral Tablet	SCD	a1a817f7-c190-4825-94eb-442f477187e3	14
198150	primidone 50 MG Oral Tablet	SCD	a1a817f7-c190-4825-94eb-442f477187e3	14
96304	primidone 250 MG Oral Tablet	PSN	a32e0a00-3ba7-47e7-83c6-a7eac5fbdd11	11
198150	primidone 50 MG Oral Tablet	PSN	a32e0a00-3ba7-47e7-83c6-a7eac5fbdd11	11
96304	primidone 250 MG Oral Tablet	SCD	a32e0a00-3ba7-47e7-83c6-a7eac5fbdd11	11
198150	primidone 50 MG Oral Tablet	SCD	a32e0a00-3ba7-47e7-83c6-a7eac5fbdd11	11
96304	primidone 250 MG Oral Tablet	PSN	c7cb2073-9d44-4261-b308-02cd24c1f17a	9
198150	primidone 50 MG Oral Tablet	PSN	c7cb2073-9d44-4261-b308-02cd24c1f17a	9
96304	primidone 250 MG Oral Tablet	SCD	c7cb2073-9d44-4261-b308-02cd24c1f17a	9
198150	primidone 50 MG Oral Tablet	SCD	c7cb2073-9d44-4261-b308-02cd24c1f17a	9
96304	primidone 250 MG Oral Tablet	PSN	e4e493bd-94d7-7e5a-e053-2995a90a2706	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	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
0527-1231-01	00527123101	100 TABLET in 1 BOTTLE (0527-1231-01)	100 tablet	1978-12-01	0000-00-00	No	No	Current
0527-1231-05	00527123105	500 TABLET in 1 BOTTLE (0527-1231-05)	500 tablet	1978-12-01	0000-00-00	No	No	Current
0527-1231-10	00527123110	1000 TABLET in 1 BOTTLE (0527-1231-10)	1000 tablet	1978-12-01	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 8020201/0821 Rx only	American Health Packaging	2024-10-03	HUMAN PRESCRIPTION DRUG LABEL	11
Primidone Tablets, USP	Lannett Company, Inc.	2020-06-11	HUMAN PRESCRIPTION DRUG LABEL	14
PRIMIDONE TABLETS, USP	NCS HealthCare of KY, Inc dba Vangard Labs	2014-12-18	HUMAN PRESCRIPTION DRUG LABEL	6
PRIMIDONE TABLETS, USP	Physicians Total Care, Inc.	2013-02-19	HUMAN PRESCRIPTION DRUG LABEL	9