NDC 0469-5020
Myrbetriq 8 mg per 1 mL granule, for suspension, extended release
On the label: Astellas Pharma US, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Astellas Ireland Co., Limited | Dublin, Ireland | Makes the active ingredient and tests it | Problems found, fixed voluntarilyJun 17, 2022 · 4 inspections |
| Astellas Pharma Inc. | Takahagi, Japan | Makes the active ingredient and tests it | Problems found, fixed voluntarilyJun 6, 2025 · 4 inspections |
| Astellas Pharma Inc. | Yaizu, Japan | Makes it and tests it | Problems found, fixed voluntarilyOct 27, 2023 · 2 inspections |
| Sumitomo Chemical Company, Limited | Kurashiki, Japan | Makes the active ingredient | No problems foundNov 2, 2023 · 3 inspections |
| Delpharm Meppel B.V. | Meppel, Netherlands | Tests it | Problems found, fixed voluntarilyOct 31, 2024 · 3 inspections |
Product details
- Generic drug
- Mirabegron: every company that makes it
- Form
- granule, for suspension, extended release, oral
- Strength
- 8 mg per 1 mL
- Approval
- NDA NDA213801
- On the market since
- Mar 25, 2021
- Package NDCs
0469-5020-99- Official label
- DailyMed (National Library of Medicine), updated Aug 1, 2024
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