NDC 70710-1160
Mirabegron 50 mg tablet, extended release
On the label: Zydus Pharmaceuticals (USA) Inc..
Where it's 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
- Jan 23, 2024
- Package NDCs
70710-1160-170710-1160-370710-1160-9- Official label
- DailyMed (National Library of Medicine), updated Oct 9, 2024
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