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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 13AFD7670Q | PRIMIDONE | 125-33-7 | PRIMIDONE |
Packages
| 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 | Historical |
| 71610-763-80 | 71610076380 | 180 TABLET in 1 BOTTLE (71610-763-80) | 180 tablet | 2023-12-13 | No | No | Historical |
| 71610-763-92 | 71610076392 | 270 TABLET in 1 BOTTLE (71610-763-92) | 270 tablet | 2023-12-13 | No | No | Historical |
| 71610-763-94 | 71610076394 | 360 TABLET in 1 BOTTLE (71610-763-94) | 360 tablet | 2023-12-13 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Primidone Tablets, USP | Aphena Pharma Solutions - Tennessee, LLC | 2024-01-09 | HUMAN PRESCRIPTION DRUG LABEL | 2 |