NDC 70710-1160 – Mirabegron
Mirabegron 50 mg/1 · Tablet, Extended Release · Oral
Product NDC70710-1160
Product details
- Brand name
- Mirabegron
- Generic name
- Mirabegron
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Dosage form
- Tablet, Extended Release
- Route
- Oral
- Marketing category
- ANDA · ANDA209488
- Marketed since
- January 23, 2024
- Listing expires
- December 31, 2026
- Pharmacologic class
- beta3-Adrenergic Agonist
Active ingredients
- Mirabegron 50 mg/1
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 70710-1160-1 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70710-1160-1) | Jan 23, 2024 |
| 70710-1160-3 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70710-1160-3) | Jan 23, 2024 |
| 70710-1160-9 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70710-1160-9) | Jan 23, 2024 |
Recalls mentioning this NDC
- D-0745-2026 Aug 12, 2026 · Class II
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
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