Primidone
- Product NDC
- 72789-178
- 11-digit product format
- 727890178
- Labeler code
- 72789
- Product ID
- 72789-178_373a4c73-f3c2-2c93-e063-6294a90ad5eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Primidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA040586
- Marketing category
- ANDA
- Marketing start
- 2021-02-22
- 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 | 96304, 198150 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-178-01 | Primidone | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 19 |
| 72789-178-82 | Primidone | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 19 |
| 72789-178-30 | Primidone | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-178 | PRIMIDONE TABLET [PD-RX PHARMACEUTICALS, INC.] | 18 | Current NDC, Legacy NDC, 2 package rows | 20240915_6046e4e9-0c1e-4d1f-85fa-d2ce25c5dc34.zip |
| 72789-178 | PRIMIDONE TABLET [PD-RX PHARMACEUTICALS, INC.] | 8 | Current NDC, Legacy NDC, 1 package rows | 20250316_0193c0a4-f593-609c-e063-6294a90aaa68.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 |
|---|
| 72789-178-01 | 72789017801 | 100 TABLET in 1 BOTTLE, PLASTIC (72789-178-01) | 100 tablet | 2021-03-30 | 0000-00-00 | No | No | Current |
| 72789-178-30 | 72789017830 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-178-30) | 30 tablet | 2023-07-28 | | No | No | Current |
| 72789-178-82 | 72789017882 | 500 TABLET in 1 BOTTLE, PLASTIC (72789-178-82) | 500 tablet | 2021-06-22 | 0000-00-00 | No | No | Current |