NDC 53746-544 – Primidone
Primidone 50 mg/1 · Tablet · Oral
Product NDC53746-544
Product details
- Brand name
- Primidone
- Generic name
- Primidone
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Dosage form
- Tablet
- Route
- Oral
- Marketing category
- ANDA · ANDA040866
- Marketed since
- December 24, 2009
- Listing expires
- December 31, 2027
- Pharmacologic class
- Anti-epileptic Agent
Active ingredients
- Primidone 50 mg/1
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 53746-544-01 | 100 TABLET in 1 BOTTLE (53746-544-01) | Dec 24, 2009 |
| 53746-544-05 | 500 TABLET in 1 BOTTLE (53746-544-05) | Dec 24, 2009 |
| 53746-544-10 | 1000 TABLET in 1 BOTTLE (53746-544-10) | Dec 24, 2009 |
Recalls mentioning this NDC
- D-0585-2026 Jun 17, 2026 · Class III
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Other Primidone products
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- 72888-160 Primidone 125 mg/1 · Tablet · Advagen Pharma Limited
- 72888-045 Primidone 50 mg/1 · Tablet · Advagen Pharma Limited
- 72888-046 Primidone 250 mg/1 · Tablet · Advagen Pharma Limited
- 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
- 65162-545 Primidone 250 mg/1 · Tablet · Amneal Pharmaceuticals LLC
- 53746-545 Primidone 250 mg/1 · Tablet · Amneal Pharmaceuticals of New York LLC
- 71610-763 Primidone 50 mg/1 · Tablet · Aphena Pharma Solutions - Tennessee, LLC
- 71610-590 Primidone 50 mg/1 · Tablet · Aphena Pharma Solutions - Tennessee, LLC
- 71610-540 Primidone 50 mg/1 · Tablet · Aphena Pharma Solutions - Tennessee, LLC