DESCRIPTION

Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride in water for injection for parenteral administration in various concentrations. Multiple-dose vials contain 0.1% methylparaben added as preservative. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH is 6.5 (5.0 to 7.0). Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is a white powder freely soluble in water. The molecular weight is 288.82. The semi-rigid vial used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.

General Surgery Kit Primary Label

MM1

Lidocaine Label

MM1

GENERAL SURGERY KIT
general surgery tray (kit) kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:24840-1507

#	Item Code	Package Description
Packaging
1	NHRIC:24840-1507-2	10 in 1 CASE
1	NHRIC:24840-1507-1	1 in 1 PACKAGE, COMBINATION

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 VIAL, MULTI-DOSE	20 mL

Part 1 of 1

LIDOCAINE HYDROCHLORIDE
lidocaine hydrochloride anhydrous injection, solution

Product Information
Item Code (Source)	NDC:0409-4277
Route of Administration	INFILTRATION

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)	6 mg in 1 mL
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
METHYLPARABEN (UNII: A2I8C7HI9T)	1 mg in 1 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0409-4277-01	20 mL in 1 VIAL, MULTI-DOSE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA088327	03/30/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
exempt device	LRO	01/01/2012

Labeler - Centurion Medical Products (017246562)

Name	Address	ID/FEI	Business Operations
Establishment
Centurion Medical Products		017246562	manufacture, repack

Name	Address	ID/FEI	Business Operations
Establishment
Centurion Medical Products		148522279	manufacture, repack

Name	Address	ID/FEI	Business Operations
Establishment
Centurion Medical Products		626660810	manufacture, repack

Name	Address	ID/FEI	Business Operations
Establishment
Hospira, Inc		093132819	repack