Dexmedetomidine Hydrochloride

Product NDC
0143-9198
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmedetomidine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA206407
Marketing category
ANDA
Substance
DEXMEDETOMIDINE HYDROCHLORIDE
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
0143-9198-1010 BAG in 1 CASE (0143-9198-10) / 250 mL in 1 BAG (0143-9198-01) 2026-03-03NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Dexmedetomidine HydrochlorideHikma Pharmaceuticals USA Inc.2026-03-04HUMAN PRESCRIPTION DRUG LABEL15