Precedex

Product NDC
0409-1596
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXMEDETOMIDINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA021038
Marketing category
NDA
Substance
DEXMEDETOMIDINE HYDROCHLORIDE
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
0409-1596-1010 CARTON in 1 CASE (0409-1596-10) / 1 BOTTLE in 1 CARTON (0409-1596-01) / 100 mL in 1 BOTTLE2023-11-13NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PrecedexHospira, Inc. | Pfizer Healthcare India Private Limited2026-05-20HUMAN PRESCRIPTION DRUG LABEL59