Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Apl Healthcare Limited | Tirupati, India | Makes it and tests it | Problems found, fixed voluntarilyDec 17, 2025 · 5 inspections |
Recalls
- Dec 6, 2024 · Class II · Aurobindo Pharma USA Inc
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Lots: Lot #: NB0224001A and NB0224001B, Exp. Date 04/2027
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Nebivolol: every company that makes it
- Form
- tablet, oral
- Strength
- 5 mg
- Approval
- ANDA ANDA211053
- On the market since
- Dec 17, 2021
- Package NDCs
59651-138-3059651-138-90- Official label
- DailyMed (National Library of Medicine), updated Mar 16, 2026
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