Dexmedetomidine Hydrochloride Injection
Mylan Institutional, a Viatris Company · Available
Open FDA's page for this record- Update type
- Reverified
- Initial posting date
- 04/10/2020
- Package NDC
- 67457-251-02
- Generic name
- Dexmedetomidine Hydrochloride Injection
- Contact info
- 800-796-9526
- Availability
- Available
- Update date
- 09/17/2026
- Dosage form
- Injection
- Presentation
- Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 67457-251-02)
- Company name
- Mylan Institutional, a Viatris Company
- Status
- Current
- Therapeutic category
- Anesthesia
- Harmonized identifiers (openFDA)
- Application number
- ANDA202881
- Brand name
- DEXMEDETOMIDINE
- Generic name
- DEXMEDETOMIDINE
- Manufacturer name
- Mylan Institutional LLC
- Product NDC
- 67457-251
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- DEXMEDETOMIDINE HYDROCHLORIDE
- RxCUI
- 309710
- SPL ID
- afa561b9-9d6c-47b3-87e6-8d049597a0ed
- SPL set ID
- ebdfe2e8-30ca-4f18-935a-41bcbbce4937
- Package NDC
- 67457-251-00, 67457-251-02
- UNII
- 1018WH7F9I