NDC 71610-858
Metformin hydrochloride 500 mg tablet, extended release
On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from Unichem Pharmaceuticals (USA), Inc.'s NDC 76385-128.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Beximco Pharmaceuticals PLC | Tongi, Bangladesh | Makes it | Problems found, fixed voluntarilyMar 30, 2023 · 2 inspections |
Repackaging site
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · relabels it
Recalls
- Aug 19, 2020 · Class II · Bayshore Pharmaceuticals
CGMP Deviations
Lots: Lot #18641; Exp. 05/2021 - Aug 19, 2020 · Class II · Bayshore Pharmaceuticals
CGMP Deviations
Lots: Lot #18657, Exp. 05/2021
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Metformin: every company that makes it
- Form
- tablet, extended release, oral
- Strength
- 500 mg
- Approval
- ANDA ANDA207427
- On the market since
- Jun 11, 2024
- Package NDCs
71610-858-3071610-858-5371610-858-6071610-858-7071610-858-8071610-858-94- Official label
- DailyMed (National Library of Medicine), updated Oct 10, 2024
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