Primidone
- Product NDC
- 52817-117
- 11-digit product format
- 528170117
- Labeler code
- 52817
- Product ID
- 52817-117_f6667426-b68b-1ac7-e053-2a95a90a905b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Primidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- TruPharma LLC.
- Application
- ANDA214896
- Marketing category
- ANDA
- Marketing start
- 2022-06-28
- Substance
- PRIMIDONE
- Active strength
- 125 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 | 125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 13AFD7670Q |
| Rxcui | 328176 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52817-117-10 | Primidone | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 52817-117-30 | Primidone | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 52817-117-50 | Primidone | 500 in 1 BOTTLE | TABLET | 500 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52817-117 | PRIMIDONE TABLET [TRUPHARMA LLC.] | 1 | Current NDC, 3 package rows | 20230309_c60b3a92-4404-4a89-b2c5-c23ff72bedad.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 52817-117-10 | 52817011710 | 100 TABLET in 1 BOTTLE (52817-117-10) | 100 tablet | 2023-02-21 | No | No | Current |
| 52817-117-30 | 52817011730 | 30 TABLET in 1 BOTTLE (52817-117-30) | 30 tablet | 2023-02-21 | No | No | Current |
| 52817-117-50 | 52817011750 | 500 TABLET in 1 BOTTLE (52817-117-50) | 500 tablet | 2023-02-21 | No | No | Current |