AMIODARONE HCL - amiodarone hcl 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.

----------

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

Preparation Label

AMIODARONE HCL 
amiodarone hcl injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52533-101
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (Amiodarone - UNII:N3RQ532IUT) AMIODARONE HYDROCHLORIDE1.8 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Dextrose (UNII: IY9XDZ35W2) 50 mg  in 1 mL
POLYSORBATE 80 (UNII: 6OZP39ZG8H) 3.6 mg  in 1 mL
BENZYL ALCOHOL (UNII: LKG8494WBH) 0.73 mg  in 1 mL
WATER (UNII: 059QF0KO0R)  
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: 8/2014
Document Id: 52c3ce04-e1b7-4cde-b0d8-c716612a0a41
Set id: 794f9f8e-44fb-4087-b76f-a7cc826f9523
Version: 5
Effective Time: 20140820
 
Cantrell Drug Company