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% of 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 soluable 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.

Cardiovascular Kit Primary Label

Lidocaine

CARDIOVASCULAR PROCEDURE KIT
cardiovascular procedure kit kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:24840-1108

#	Item Code	Package Description
Packaging
1	NHRIC:24840-1108-2	10 in 1 CASE
1	NHRIC:24840-1108-1	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:0409-4276
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	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)	7 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:0409-4276-01	20 mL in 1 VIAL, MULTI-DOSE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA088299	03/30/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
exempt device	OEZ	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	manufacture

Cardiovascular Procedure Kit

DESCRIPTION

Cardiovascular Kit Primary Label

Lidocaine