50
0.5%
X
X
0.5% 1:200,000
X
1%
X
X
X
X
X
X
X
X
X
X
1% 1:100,000
X
X
X
1% 1:200,000
X
X
X
1.5%
X
X
1.5% 1:200,000
X
X
X
X
2%
X
X
X
X
X
X
X
2% 1:100,000
X
X
2% 1:200,000
X
X
X
All solutions should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from light.
APP
APP Pharmaceuticals, LLC
Schaumburg, IL. 60173
451175B
Revised: March 2010
PACKAGE LABEL
XYLOCAINE
lidocaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52584-484(NDC:63323-484)
Route of Administration INFILTRATION,PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lidocaine Hydrochloride (Lidocaine) Lidocaine Hydrochloride 5mg in1mL
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52584-484-57 1 VIAL ( VIAL) in 1 BAG contains a VIAL
1 50 mL in 1 VIAL This package is contained within the BAG(52584-484-57)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA006488 09/21/2011
Labeler -General Injectables & Vaccines, Inc (108250663)
