NDC 67046-0437
Metformin 500 mg tablet, extended release
On the label: Coupler LLC. It's repackaged: Coupler LLC rebottles it from Granules Pharmaceuticals Inc.'s NDC 70010-491.
Where the pills inside were made
This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Granules Pharmaceuticals Inc. names for other drugs.
Repackaging site
- Coupler LLC, West Chester, PA, United States · repackages it
Recalls
- Jul 3, 2020 · Class II · Granules Pharmaceuticals Inc
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Lots: a) 100 count 4920003A/May-21 4920004A/Jun-21 4920005A/Jun-21 4920009A/Nov-21 4920010A/May-22 4920011A/Jun-22 4920012A/Jun-22 4920013A/Jul-22 4920014A/Jul-22 4920015A/Aug-22 4920016A/Jan-23 b) 500 count 4920005B/Jun-21
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 ANDA209313
- On the market since
- Jun 16, 2026
- Package NDCs
67046-0437-3- Official label
- DailyMed (National Library of Medicine), updated Jun 16, 2026
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