NDC 71610-578
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 Ascend Laboratories, LLC's NDC 67877-413.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alkem Laboratories Limited | Baddi Solan, India | Makes it | Problems found, fixed voluntarilyMar 27, 2024 · 9 inspections |
Repackaging site
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it
Recalls
- Nov 2, 2016 · Class II · Ascend Laboratories LLC
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
Lots: Lot 6121056, exp 5/2019
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 ANDA206145
- On the market since
- Oct 27, 2018
- Package NDCs
71610-578-6071610-578-7071610-578-8071610-578-94- Official label
- DailyMed (National Library of Medicine), updated Aug 2, 2021
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