NDC 68180-336
Metformin Hydrochloride 500 mg tablet, extended release
On the label: Lupin Pharmaceuticals, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Salcette, India | Makes it and packages it | Problems found, fixed voluntarilyNov 21, 2025 · 9 inspections, 1 with FDA action |
Recalls
- Jul 7, 2020 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Lots: Batch # G808293 Aug-20 G808284 Aug-20 G808285 Aug-20 G808343 Aug-20 G901201 Dec-20 G901202 Dec-20 G906915 Jul-21 G906913 Jul-21 G906914 Jul-21 G002135 Jan-22 G002849 Feb-22 - Jun 11, 2020 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Lots: Batch # G901203, exp. date 12/2020
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 ANDA090692
- On the market since
- Sep 30, 2011
- Package NDCs
68180-336-0168180-336-0268180-336-07- Official label
- DailyMed (National Library of Medicine), updated Sep 9, 2026
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