NDC 65219-642
Dexmedetomidine Hydrochloride 100 ug per 1 mL injection, solution
On the label: Fresenius Kabi USA, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Grand Island, NY, United States | Makes it and tests it | Problems found, fixed voluntarilyOct 13, 2023 · 14 inspections, 2 with FDA action |
Product details
- Generic drug
- Dexmedetomidine: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 100 ug per 1 mL
- Approval
- ANDA ANDA201072
- On the market since
- Sep 18, 2015
- Package NDCs
65219-642-0165219-642-02- Official label
- DailyMed (National Library of Medicine), updated Jan 23, 2026
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