Precedex
- Product NDC
- 0409-7838
- 11-digit product format
- 004097838
- Labeler code
- 0409
- Product ID
- 0409-7838_3c5274fd-6597-4b88-babc-92e4e16c6329
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DEXMEDETOMIDINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hospira, Inc.
- Application
- NDA021038
- Marketing category
- NDA
- Marketing start
- 2025-03-24
- Substance
- DEXMEDETOMIDINE HYDROCHLORIDE
- Active strength
- 4 ug/mL
- Pharmacologic classes
- Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 1018WH7F9I | DEXMEDETOMIDINE HYDROCHLORIDE | 145108-58-3 | DEXMEDETOMIDINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0409-7838-24 | 00409783824 | 24 POUCH in 1 CASE (0409-7838-24) / 1 BAG in 1 POUCH / 50 mL in 1 BAG (0409-7838-01) | 24 pouch | 2025-03-24 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Precedex | Hospira, Inc. | Pfizer Healthcare India Private Limited | 2026-05-20 | HUMAN PRESCRIPTION DRUG LABEL | 59 |