Dexmedetomidine Hydrochloride Injection
Pfizer Inc. · Available
Open FDA's page for this record- Update type
- Reverified
- Initial posting date
- 04/10/2020
- Package NDC
- 0409-3301-10
- Generic name
- Dexmedetomidine Hydrochloride Injection
- Contact info
- 844-646-4398
- Availability
- Available
- Update date
- 09/08/2026
- Dosage form
- Injection
- Presentation
- Precedex, Injection, 80 mcg/20 mL (4 mcg/mL) (NDC 0409-3301-10)
- Company name
- Pfizer Inc.
- Status
- Current
- Therapeutic category
- Anesthesia
- Harmonized identifiers (openFDA)
- Application number
- NDA021038
- Brand name
- PRECEDEX
- Generic name
- DEXMEDETOMIDINE HYDROCHLORIDE
- Manufacturer name
- Hospira, Inc.
- Product NDC
- 0409-3301, 0409-1454, 0409-1174, 0409-2815
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- DEXMEDETOMIDINE HYDROCHLORIDE
- RxCUI
- 1718900, 1718902, 1718906, 1718907, 1718909, 1718910, 2396891, 2396892
- SPL ID
- e1705533-5a85-441f-a95b-3cb88c47e482
- SPL set ID
- 4419162d-81d4-49bd-96de-1729440bdb74
- Package NDC
- 0409-1454-01, 0409-1454-20, 0409-3301-01, 0409-3301-10, 0409-1174-01, 0409-1174-10, 0409-2815-01
- UNII
- 1018WH7F9I