Primidone
- Product NDC
- 71610-540
- 11-digit product format
- 716100540
- Labeler code
- 71610
- Product ID
- 71610-540_11c79cec-987d-4bce-b8ce-ba3edbe60dc6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Primidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- 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
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 |
|---|
| 71610-540-09 | 71610054009 | 9000 TABLET in 1 BOTTLE, PLASTIC (71610-540-09) | 9000 tablet | 2021-06-28 | No | No | Historical |
| 71610-540-60 | 71610054060 | 90 TABLET in 1 BOTTLE, PLASTIC (71610-540-60) | 90 tablet | 2021-04-06 | No | No | Historical |
| 71610-540-80 | 71610054080 | 180 TABLET in 1 BOTTLE, PLASTIC (71610-540-80) | 180 tablet | 2021-04-06 | No | No | Historical |
| 71610-540-92 | 71610054092 | 270 TABLET in 1 BOTTLE, PLASTIC (71610-540-92) | 270 tablet | 2021-04-06 | No | No | Historical |
| 71610-540-94 | 71610054094 | 360 TABLET in 1 BOTTLE, PLASTIC (71610-540-94) | 360 tablet | 2021-09-20 | No | No | Historical |