Drug Description

AQUEOUS SOLUTIONS FOR INFILTRATION

AND NERVE BLOCK

Ampul

Plastic Multiple-dose Fliptop Vial

Glass Teartop Vial

Rx only

DESCRIPTION

Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride in water for injection for parenteral administration in various concentrations with characteristics as follows:

Concentration 0.5% 1% 1.5% 2%

mg/mL lidocaine HCl (anhyd.) 5 10 15 20

mg/mL sodium chloride 8 7 6.5 6

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 chemically designated 2-(diethylamino)-N-(2,6-dimethylphenyl)-acetamide monohydrochloride monohydrate, a white powder freely soluble in water. The molecular weight is 288.82.

Cardiovascular Procedure Kit - Primary Label

MM1

CARDIOVASCULAR PROCEDURE KIT
cardiovascular procedure kit kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:24840-1103

#	Item Code	Package Description
Packaging
1	NHRIC:24840-1103-2	10 in 1 CASE
1	NHRIC:24840-1103-1	1 in 1 PACKAGE, COMBINATION

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 AMPULE	20 mL

Part 1 of 1

LIDOCAINE HYDROCHLORIDE
lidocaine hydrochloride anhydrous injection, solution

Product Information
Item Code (Source)	NDC:0409-4776
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	15 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Sodium Chloride (UNII: 451W47IQ8X)	6.5 mg in 1 mL
Water (UNII: 059QF0KO0R)
Sodium Hydroxide (UNII: 55X04QC32I)
Hydrochloric Acid (UNII: QTT17582CB)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0409-4776-01	20 mL in 1 AMPULE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA080408	03/30/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
exempt device	OEZ	02/20/2012

Labeler - Centurion Medical Products (017246562)

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		093132819	manufacture