Esmolol Hydrochloride

ESMOLOL HYDROCHLORIDE- esmolol hydrochloride injection, solution
Mylan Teoranta

PRINCIPAL DISPLAY PANEL — 100 mg/10 mL

NDC 67457-182-10

Esmolol Hydrochloride Injection 100 mg/ 10 mL Carton Labels
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ESMOLOL HYDROCHLORIDE
esmolol hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63286-0182
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESMOLOL HYDROCHLORIDE (ESMOLOL) ESMOLOL HYDROCHLORIDE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM ACETATE ANHYDROUS
ACETIC ACID
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63286-0182-1 10 VIAL in 1 CARTON contains a VIAL
1 10 mL in 1 VIAL This package is contained within the CARTON (63286-0182-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076474 05/09/2013 05/10/2013
Labeler — Mylan Teoranta (896321325)

Revised: 04/2012 Mylan Teoranta

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