NDC 83270-178
Labetalol Hydrochloride 5 mg per 1 mL injection
On the label: Onesource Specialty Pharma Limited.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Onesource Specialty Pharma Limited | Bengaluru, India | Makes it, tests it, packages it, labels it and sterilizes it | Problems found, fixed voluntarilyJun 30, 2026 · 9 inspections, 1 with FDA action |
Product details
- Generic drug
- Labetalol: every company that makes it
- Form
- injection, intravenous
- Strength
- 5 mg per 1 mL
- Approval
- ANDA ANDA079134
- On the market since
- Feb 27, 2026
- Package NDCs
83270-178-01- Official label
- DailyMed (National Library of Medicine), updated Jun 29, 2026
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