PRECEDEX
- Product NDC
- 52584-638
- 11-digit product format
- 525840638
- Labeler code
- 52584
- Product ID
- 52584-638_7cfa5459-ca61-4057-8629-4c19a3e5fe1f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DEXMEDETOMIDINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- General Injectables and Vaccines, Inc.
- Application
- NDA021038
- Marketing category
- NDA
- Marketing start
- 2018-07-02
- Marketing end
- 2023-09-01
- Substance
- DEXMEDETOMIDINE HYDROCHLORIDE
- Active strength
- 100 ug/mL
- Pharmacologic classes
- Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52584-638-02 | 52584063802 | 1 VIAL in 1 BAG (52584-638-02) > 2 mL in 1 VIAL | 1 vial | 2018-07-02 | 0000-00-00 | No | No | Current |