NDC 70518-4304
Mirabegron 50 mg tablet, extended release
On the label: Remedyrepack Inc.. It's repackaged: Remedyrepack Inc. rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 70710-1160.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyMar 24, 2023 · 5 inspections |
Recalls
- Aug 5, 2026 · Class II · Zydus Pharmaceuticals (USA) Inc
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Lots: Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Mirabegron: every company that makes it
- Form
- tablet, extended release, oral
- Strength
- 50 mg
- Approval
- ANDA ANDA209488
- On the market since
- Mar 7, 2025
- Package NDCs
70518-4304-0- Official label
- DailyMed (National Library of Medicine), updated Sep 3, 2026
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