NDC 16729-432
Dexmedetomidine 100 ug per 1 mL injection, solution
On the label: Accord Healthcare Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | No problems foundJul 12, 2024 · 10 inspections |
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | Serious problems, FDA actionDec 2, 2022 · 7 inspections, 1 with FDA action |
Product details
- Generic drug
- Dexmedetomidine: every company that makes it
- Form
- injection, solution
- Strength
- 100 ug per 1 mL
- Approval
- ANDA ANDA204023
- On the market since
- Aug 31, 2018
- Package NDCs
16729-432-3016729-432-93- Official label
- DailyMed (National Library of Medicine), updated Aug 18, 2020
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