Esmolol Hydrochloride

Product NDC
70518-4410
11-digit product format
705184410
Labeler code
70518
Product ID
70518-4410_3b14985c-f435-be98-e063-6294a90a0f92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esmolol Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
ANDA205520
Marketing category
ANDA
Marketing start
2025-07-29
Substance
ESMOLOL HYDROCHLORIDE
Active strength
100 mg/10mL
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
70518-4410-07051844100025 VIAL, SINGLE-DOSE in 1 CARTON (70518-4410-0) / 10 mL in 1 VIAL, SINGLE-DOSE (70518-4410-1) 2025-07-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Esmolol HydrochlorideREMEDYREPACK INC.2025-07-29HUMAN PRESCRIPTION DRUG LABEL1