Primidone
- Product NDC
- 72888-046
- 11-digit product format
- 728880046
- Labeler code
- 72888
- Product ID
- 72888-046_48453b30-812c-76c6-e063-6394a90ad9a0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Primidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advagen Pharma Limited
- Application
- ANDA214896
- Marketing category
- ANDA
- Marketing start
- 2022-06-28
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Primidone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PRIMIDONE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 13AFD7670Q |
| Rxcui | 96304, 198150, 328176 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72888-046-01 | Primidone | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 72888-046-05 | Primidone | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72888-046 | PRIMIDONE TABLET [ADVAGEN PHARMA LIMITED] | 2 | Current NDC, Legacy NDC, 2 package rows | 20230112_b3b94d2e-6a64-45b7-b0cb-0fde689240d8.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 |
|---|
| 72888-046-01 | 72888004601 | 100 TABLET in 1 BOTTLE (72888-046-01) | 100 tablet | 2022-06-28 | 0000-00-00 | No | No | Current |
| 72888-046-05 | 72888004605 | 500 TABLET in 1 BOTTLE (72888-046-05) | 500 tablet | 2022-06-28 | 0000-00-00 | No | No | Current |