AMIODARONE HCL injection, solution

Amiodarone HCl by

Drug Labeling and Warnings

Amiodarone HCl by is a Prescription medication manufactured, distributed, or labeled by Cantrell Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

SPL UNCLASSIFIED SECTION

INGREDIENTS AND APPEARANCE

AMIODARONE HCL 
amiodarone hcl injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 52533-101
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (Amiodarone - UNII:N3RQ532IUT)	AMIODARONE HYDROCHLORIDE	1.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52533-101-59	500 mL in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/18/2013

Labeler - Cantrell Drug Company (035545763)