Mysoline
- Product NDC
- 66490-691
- 11-digit product format
- 664900691
- Labeler code
- 66490
- Product ID
- 66490-691_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
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mysoline
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PRIMIDONE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 13AFD7670Q |
| Rxcui | 96304, 198150, 201747, 207478 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66490-691-10 | Mysoline | 100 in 1 BOTTLE | TABLET | 100 | | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66490-691 | MYSOLINE (PRIMIDONE) TABLET [BAUSCH HEALTH US, LLC] | 10 | Current NDC, Legacy NDC, 1 package rows | 20200812_af593171-dabb-4ea3-b44c-89ed457b2c46.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 66490-691-10 | 66490069110 | 100 TABLET in 1 BOTTLE (66490-691-10) | 100 tablet | 2009-06-24 | 0000-00-00 | No | No | Current |