ESMOLOL HYDROCHLORIDE- esmolol hydrochloride injection, solution 
Mylan Teoranta

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PRINCIPAL DISPLAY PANEL - 100 mg/10 mL

NDC 67457-182-10

Esmolol Hydrochloride Injection 100 mg/ 10 mL Carton Labels
ESMOLOL HYDROCHLORIDE 
esmolol hydrochloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:63286-0182
Route of AdministrationINTRAVENOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESMOLOL HYDROCHLORIDE (ESMOLOL) ESMOLOL HYDROCHLORIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM ACETATE ANHYDROUS 
ACETIC ACID 
SODIUM HYDROXIDE 
HYDROCHLORIC ACID 
WATER 
Packaging
#Item CodePackage Description
1NDC:63286-0182-110 in 1 CARTON
110 mL in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07647402/28/2013
Labeler - Mylan Teoranta (896321325)

Revised: 04/2012
Document Id: 8932c1a7-0095-4c8f-be5d-c3dccd443c57
Set id: 8932c1a7-0095-4c8f-be5d-c3dccd443c57
Version: 1
Effective Time: 20120430
 
Mylan Teoranta