NDC 71610-920
Metformin Hydrochloride 500 mg tablet, film coated
On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from Aurobindo Pharma Limited's NDC 65862-008.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited | Medchal, India | Makes it and tests it | Problems found, fixed voluntarilyJul 21, 2023 · 13 inspections, 1 with FDA action |
| Aurobindo Pharma Limited | Mahabubnagar, India | Makes it and tests it | Problems found, fixed voluntarilyMay 10, 2022 · 7 inspections, 1 with FDA action |
Repackaging site
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it
Recalls
- Feb 2, 2018 · Class III · Aurobindo Pharma Ltd.
Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
Lots: Lot#: MTSC17145-A, Exp. July 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, film coated, oral
- Strength
- 500 mg
- Approval
- ANDA ANDA077095
- On the market since
- Jan 14, 2005
- Package NDCs
71610-920-5371610-920-6071610-920-80- Official label
- DailyMed (National Library of Medicine), updated Jul 3, 2025
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