NDC 70121-1389
Dexmedetomidine Hydrochloride 4 ug per 1 mL injection, solution
On the label: Amneal Pharmaceuticals LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals Private Limited | Ahmedabad, India | Makes it, tests it, packages it and sterilizes it | No problems foundJun 19, 2024 · 7 inspections |
| Amneal Pharmaceuticals Private Limited | Mehsana, India | Makes it, tests it, packages it, labels it and sterilizes it | Not inspected on record |
| Maiva Pharma Private Limited | Hosur, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyOct 29, 2022 · 1 inspection |
Product details
- Generic drug
- Dexmedetomidine: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 4 ug per 1 mL
- Approval
- ANDA ANDA207551
- On the market since
- May 20, 2020
- Package NDCs
70121-1389-170121-1389-7- Official label
- DailyMed (National Library of Medicine), updated May 28, 2026
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