Esmolol Hydrochloride

Product NDC
63323-661
11-digit product format
633230661
Labeler code
63323
Product ID
63323-661_961c04d5-1f12-4095-a4b9-1842574f7f97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESMOLOL HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA076573
Marketing category
ANDA
Marketing start
2004-11-30
Substance
ESMOLOL HYDROCHLORIDE
Active strength
10 mg/mL
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
V05260LC8DESMOLOL HYDROCHLORIDE81161-17-3ESMOLOL HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63323-661-146332306611425 VIAL, SINGLE-DOSE in 1 TRAY (63323-661-14) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-661-04) 2025-01-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Esmolol HydrochlorideFresenius Kabi USA, LLC2024-11-14HUMAN PRESCRIPTION DRUG LABEL6