NDC 0527-1231 – Primidone
Primidone 250 mg/1 · Tablet · Oral
Product NDC0527-1231
Product details
- Brand name
- Primidone
- Generic name
- Primidone
- Labeler
- Lannett Company, Inc.
- Dosage form
- Tablet
- Route
- Oral
- Marketing category
- ANDA · ANDA084903
- Marketed since
- December 1, 1978
- Listing expires
- December 31, 2026
- Pharmacologic class
- Anti-epileptic Agent
Active ingredients
- Primidone 250 mg/1
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 0527-1231-01 | 100 TABLET in 1 BOTTLE (0527-1231-01) | Dec 1, 1978 |
| 0527-1231-05 | 500 TABLET in 1 BOTTLE (0527-1231-05) | Dec 1, 1978 |
| 0527-1231-10 | 1000 TABLET in 1 BOTTLE (0527-1231-10) | Dec 1, 1978 |
Recalls mentioning this NDC
- D-0533-2026 May 27, 2026 · Class III
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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- 68084-202 Primidone 50 mg/1 · Tablet · American Health Packaging
- 68084-203 Primidone 250 mg/1 · Tablet · American Health Packaging
- 65162-544 Primidone 50 mg/1 · Tablet · Amneal Pharmaceuticals LLC
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- 53746-544 Primidone 50 mg/1 · Tablet · Amneal Pharmaceuticals of New York LLC
- 53746-545 Primidone 250 mg/1 · Tablet · Amneal Pharmaceuticals of New York LLC
- 71610-590 Primidone 50 mg/1 · Tablet · Aphena Pharma Solutions - Tennessee, LLC
- 71610-763 Primidone 50 mg/1 · Tablet · Aphena Pharma Solutions - Tennessee, LLC