NDC 0338-9557
Dexmedetomidine Hydrochloride 400 ug per 100 mL injection
On the label: Baxter Healthcare Corporation.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Baxter Healthcare Corporation | Round Lake, IL, United States | Makes it, tests it, packages it, labels it and sterilizes it | Serious problems, FDA actionApr 2, 2026 · 15 inspections, 2 with FDA action |
Recalls
- Aug 6, 2026 · Class II · Baxter Healthcare Corporation
CGMP Deviations
Lots: Lot # NC188654, Exp Date: 08/31/2027; Lot # NC188821, Exp Date: 09/30/2027; Lot # NC193658, NC193702, Exp Date: 01/31/2028.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Dexmedetomidine: every company that makes it
- Form
- injection, intravenous
- Strength
- 400 ug per 100 mL
- Approval
- ANDA ANDA208532
- On the market since
- Aug 21, 2018
- Package NDCs
0338-9557-12- Official label
- DailyMed (National Library of Medicine), updated May 7, 2026
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