AMIODARONE HCL - amiodarone hydrochloride injection, solution 
Cantrell Drug Company

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Amiodarone HCl 900 mg Added to 5% Dextrose 500 mL Bag

Preparation Label

AMIODARONE HCL 
amiodarone hcl injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:52533-101
Route of AdministrationINTRAVENOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMIODARONE HYDROCHLORIDE (Amiodarone) AMIODARONE HYDROCHLORIDE1.8 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Dextrose50 mg  in 1 mL
Water 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52533-101-59500 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/2013
Labeler - Cantrell Drug Company (035545763)

Revised: 10/2013
 
Cantrell Drug Company