NDC 68083-527
Dexmedetomidine 100 ug per 1 mL injection, solution
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, solution, intravenous
- Strength
- 100 ug per 1 mL
- Approval
- ANDA ANDA202126
- On the market since
- Jun 28, 2021
- Package NDCs
68083-527-25- Official label
- DailyMed (National Library of Medicine), updated May 19, 2026
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