PRIMIDONE
- Product NDC
- 72189-216
- 11-digit product format
- 721890216
- Labeler code
- 72189
- Product ID
- 72189-216_2be9877c-0b1e-23b4-e063-6394a90af68f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PRIMIDONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA040586
- Marketing category
- ANDA
- Marketing start
- 2021-05-11
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PRIMIDONE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PRIMIDONE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 13AFD7670Q |
| Rxcui | 198150 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-216-60 | PRIMIDONE | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-216 | PRIMIDONE TABLET [DIRECT RX] | 2 | Current NDC, Legacy NDC, 1 package rows | 20250119_c20f803c-e965-9dd8-e053-2995a90a92ba.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 |
|---|
| 72189-216-60 | 72189021660 | 60 TABLET in 1 BOTTLE (72189-216-60) | 60 tablet | 2021-05-11 | 0000-00-00 | No | No | Current |