NDC 68083-657
Dexmedetomidine Hydrochloride 4 ug per 1 mL injection
On the label: Gland Pharma Limited.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Gland Pharma Limited | Hyderabad, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyJul 25, 2024 · 7 inspections |
| Gland Pharma Limited | Hyderabad, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyJun 27, 2023 · 4 inspections |
Product details
- Generic drug
- Dexmedetomidine: every company that makes it
- Form
- injection, intravenous
- Strength
- 4 ug per 1 mL
- Approval
- ANDA ANDA209307
- On the market since
- Dec 19, 2024
- Package NDCs
68083-657-10- Official label
- DailyMed (National Library of Medicine), updated May 20, 2026
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