NDC 68462-521
Metformin Hydrochloride 1000 mg tablet, film coated, extended release
On the label: Glenmark Pharmaceuticals Inc., USA.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Limited | Dhar, India | Makes it and tests it | Serious problems, FDA actionFeb 14, 2025 · 8 inspections, 1 with FDA action |
Recalls
- Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: Lot # 17232088, exp. date Sep-25 17232093, exp. date Sep-25
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, extended release, oral
- Strength
- 1000 mg
- Approval
- ANDA ANDA212969
- On the market since
- Nov 25, 2019
- Package NDCs
68462-521-0168462-521-0568462-521-90- Official label
- DailyMed (National Library of Medicine), updated Sep 23, 2026
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