Mysoline

Product NDC: 66490-690
11-digit product format: 664900690
Labeler code: 66490
Product ID: 66490-690_9d9f03b1-4eb4-4ba5-a357-600e368802c6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Primidone
Dosage form: TABLET
Route: ORAL
Labeler: Bausch Health US, LLC
Application: NDA009170
Marketing category: NDA
Marketing start: 2009-06-24
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: 2026-12-31
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
N009170-002	MYSOLINE	PRIMIDONE	250MG	TABLET / ORAL	AB	RLD, Approved before 1982
N009170-003	MYSOLINE	PRIMIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N009170-002	AB
N009170-003	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	Source SHA-256
2026-08-18 06:07:40	2026-07	N009170-002	MYSOLINE	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009170-003	MYSOLINE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N009170-002	MYSOLINE	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009170-003	MYSOLINE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009170-002	MYSOLINE	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009170-003	MYSOLINE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009170-002	MYSOLINE	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009170-003	MYSOLINE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009170-002	MYSOLINE	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009170-003	MYSOLINE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009170-002	MYSOLINE	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009170-003	MYSOLINE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009170-002	MYSOLINE	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009170-003	MYSOLINE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009170-002	MYSOLINE	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009170-003	MYSOLINE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009170-002	MYSOLINE	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009170-003	MYSOLINE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009170-002	MYSOLINE	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009170-003	MYSOLINE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N009170-002	MYSOLINE	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N009170-003	MYSOLINE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009170-002	MYSOLINE	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009170-003	MYSOLINE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009170-002	MYSOLINE	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009170-003	MYSOLINE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009170-002	MYSOLINE	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009170-003	MYSOLINE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N009170-002	MYSOLINE	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N009170-003	MYSOLINE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N009170-002	MYSOLINE	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N009170-003	MYSOLINE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N009170-002	MYSOLINE	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N009170-003	MYSOLINE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N009170-002	MYSOLINE	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N009170-003	MYSOLINE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N009170-002	MYSOLINE	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N009170-003	MYSOLINE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N009170-002	MYSOLINE	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N009170-003	MYSOLINE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`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	N009170-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009170-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N009170-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009170-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009170-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009170-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009170-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009170-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009170-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009170-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009170-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009170-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009170-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009170-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009170-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009170-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009170-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009170-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009170-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009170-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N009170-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N009170-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009170-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009170-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009170-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009170-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009170-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009170-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N009170-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N009170-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N009170-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N009170-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N009170-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N009170-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N009170-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N009170-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N009170-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N009170-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N009170-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N009170-003	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRIMIDONE	50 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
96304	Internal RxNorm lookup
198150	Internal RxNorm lookup
201747	Internal RxNorm lookup
207478	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
af593171-dabb-4ea3-b44c-89ed457b2c46	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	Strength	SPL version
66490-690-10	Mysoline	100 in 1 BOTTLE	TABLET	100		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66490-690-10	EA - Each	66490-690	99996378-3a6d-4f73-ad52-3f472f9c2364	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Primidone	ACTIVE INGREDIENT	13AFD7670Q	MYSOLINE (PRIMIDONE) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA]	5
Primidone	ACTIVE MOIETY	13AFD7670Q	MYSOLINE (PRIMIDONE) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA]	5
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	MYSOLINE (PRIMIDONE) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA]	5
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	MYSOLINE (PRIMIDONE) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA]	5
lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	MYSOLINE (PRIMIDONE) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA]	5
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	MYSOLINE (PRIMIDONE) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA]	5
Methylcellulose (15 CPS)	INACTIVE INGREDIENT	NPU9M2E6L8	MYSOLINE (PRIMIDONE) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA]	5
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	MYSOLINE (PRIMIDONE) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA]	5
sodium starch glycolate type a potato	INACTIVE INGREDIENT	5856J3G2A2	MYSOLINE (PRIMIDONE) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA]	5
talc	INACTIVE INGREDIENT	7SEV7J4R1U	MYSOLINE (PRIMIDONE) TABLET [VALEANT PHARMACEUTICALS NORTH AMERICA]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66490-690	MYSOLINE (PRIMIDONE) TABLET [BAUSCH HEALTH US, LLC]	10	Current NDC, Legacy NDC, 1 package rows	20200812_af593171-dabb-4ea3-b44c-89ed457b2c46.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mysoline	PRIMIDONE	Bausch Health US, LLC	af593171-dabb-4ea3-b44c-89ed457b2c46	2020-07-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 009170 application number: NDA009170 ndc (product): 66490-690

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
201747	Mysoline 250 MG Oral Tablet	PSN	af593171-dabb-4ea3-b44c-89ed457b2c46	10
207478	Mysoline 50 MG Oral Tablet	PSN	af593171-dabb-4ea3-b44c-89ed457b2c46	10
96304	primidone 250 MG Oral Tablet	PSN	af593171-dabb-4ea3-b44c-89ed457b2c46	10
198150	primidone 50 MG Oral Tablet	PSN	af593171-dabb-4ea3-b44c-89ed457b2c46	10
201747	primidone 250 MG Oral Tablet [Mysoline]	SBD	af593171-dabb-4ea3-b44c-89ed457b2c46	10
207478	primidone 50 MG Oral Tablet [Mysoline]	SBD	af593171-dabb-4ea3-b44c-89ed457b2c46	10
96304	primidone 250 MG Oral Tablet	SCD	af593171-dabb-4ea3-b44c-89ed457b2c46	10
198150	primidone 50 MG Oral Tablet	SCD	af593171-dabb-4ea3-b44c-89ed457b2c46	10
201747	Mysoline 250 MG Oral Tablet	SY	af593171-dabb-4ea3-b44c-89ed457b2c46	10
207478	Mysoline 50 MG Oral Tablet	SY	af593171-dabb-4ea3-b44c-89ed457b2c46	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66490-690-10	66490069010	100 TABLET in 1 BOTTLE (66490-690-10)	100 tablet	2009-06-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mysoline ® (primidone tablets, USP) 50 mg and 250 mg Rx only Anticonvulsant	Bausch Health US, LLC \| Bausch Health Companies Inc.	2020-07-06	HUMAN PRESCRIPTION DRUG LABEL	10