AMIKACIN SULFATE INJECTION, 500 MG/2ML injection

Amikacin Sulfate Injection, 500 mg/2ml by

Drug Labeling and Warnings

Amikacin Sulfate Injection, 500 mg/2ml by is a Prescription medication manufactured, distributed, or labeled by Safrel Pharmaceuticals, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AMIKACIN SULFATE INJECTION, 500 MG/2ML 
amikacin sulfate injection, 500 mg/2ml injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 71309-996
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMIKACIN SULFATE (UNII: N6M33094FD) (AMIKACIN - UNII:84319SGC3C)	AMIKACIN	500 mg

Inactive Ingredients
Ingredient Name	Strength
SULFURIC ACID (UNII: O40UQP6WCF)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71309-996-05	500 in 1 VIAL; Type 0: Not a Combination Product	08/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		08/01/2020

Labeler - Safrel Pharmaceuticals, LLC. (080566287)