NDC 71335-9683
Metformin Hydrochloride 500 mg tablet, extended release
On the label: Bryant Ranch Prepack. It's repackaged: Bryant Ranch Prepack rebottles it from Nostrum Laboratories, Inc.'s NDC 29033-055.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Nostrum Laboratories, Inc. | Bryan, Ohio, United States | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyMar 13, 2025 · 6 inspections |
Repackaging site
- Bryant Ranch Prepack, Burbank, CA, United States · repackages it and relabels it
Recalls
- Oct 23, 2020 · Class II · Nostrum Laboratories Inc
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Lots: MET100201, MET100401 EXP 05/2022
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 ANDA076756
- On the market since
- Aug 6, 2020
- Package NDCs
71335-9683-171335-9683-271335-9683-371335-9683-471335-9683-571335-9683-671335-9683-771335-9683-871335-9683-9- Official label
- DailyMed (National Library of Medicine), updated Apr 11, 2023
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