NDC 53401-008
Naltrexone Hydrochloride 50 mg tablet, film coated
On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from TAGI Pharma, Inc.'s NDC 51224-206.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Elite Laboratories, Inc. | Northvale, NJ, United States | Makes it | Problems found, fixed voluntarilyAug 1, 2025 · 12 inspections, 1 with FDA action |
Repackaging site
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it
Product details
- Generic drug
- Naltrexone: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 50 mg
- Approval
- ANDA ANDA075274
- On the market since
- Mar 26, 2015
- Package NDCs
53401-008-31- Official label
- DailyMed (National Library of Medicine), updated Apr 14, 2026
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