Primidone
- Product NDC
- 71610-763
- 11-digit product format
- 716100763
- Labeler code
- 71610
- Product ID
- 71610-763_00e54b53-17fb-4504-994d-8aafa70511eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Primidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA084903
- Marketing category
- ANDA
- Marketing start
- 2001-05-24
- 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 |
|---|
| 71610-763-60 | Primidone | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
| 71610-763-80 | Primidone | 180 in 1 BOTTLE | TABLET | 180 | | 2 |
| 71610-763-92 | Primidone | 270 in 1 BOTTLE | TABLET | 270 | | 2 |
| 71610-763-94 | Primidone | 360 in 1 BOTTLE | TABLET | 360 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-763 | PRIMIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Current NDC, 4 package rows | 20240110_ad8b50e2-e797-4326-a57e-d254da85b6b9.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 |
|---|
| 71610-763-60 | 71610076360 | 90 TABLET in 1 BOTTLE (71610-763-60) | 90 tablet | 2024-01-09 | No | No | Current |
| 71610-763-80 | 71610076380 | 180 TABLET in 1 BOTTLE (71610-763-80) | 180 tablet | 2023-12-13 | No | No | Current |
| 71610-763-92 | 71610076392 | 270 TABLET in 1 BOTTLE (71610-763-92) | 270 tablet | 2023-12-13 | No | No | Current |
| 71610-763-94 | 71610076394 | 360 TABLET in 1 BOTTLE (71610-763-94) | 360 tablet | 2023-12-13 | No | No | Current |