NDC 68645-595
Metformin 500 mg tablet, extended release
On the label: Legacy Pharmaceutical Packaging.
It's a repackaged product: Legacy Pharmaceutical Packaging 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 aren't required to print it on the label. The manufacturer's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Granules Pharmaceuticals Inc. uses for other drugs.
Recalls
- Jul 3, 2020 · Class II · Ongoing
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
Product details
- Generic drug
- Metformin: see every company that makes it
- Form
- tablet, extended release, oral
- Strength
- 500 mg
- Approval
- ANDA ANDA209313
- On the market since
- Mar 10, 2022
- Package NDCs
68645-595-59- Official label
- DailyMed (National Library of Medicine), updated Mar 11, 2026
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