NDC 71610-964
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 SpecGx LLC's NDC 0406-1170.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| SpecGx LLC | Hobart, NY, United States | Makes it and tests it | No problems foundMar 13, 2020 · 6 inspections |
Repackaging site
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it
Recalls
- Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Naltrexone: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 50 mg
- Approval
- ANDA ANDA076264
- On the market since
- Mar 22, 2002
- Package NDCs
71610-964-31- Official label
- DailyMed (National Library of Medicine), updated Nov 17, 2025
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