OB GYN PROCEDURE KIT- kit

OB GYN Procedure Kit by

Drug Labeling and Warnings

OB GYN Procedure Kit by is a Other medication manufactured, distributed, or labeled by Centurion Medical Products, Hospira Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration. Sodium metabisulfate 0.5 mg/ml and citric acid, anhydrous 0.2 mg/ml added as stabilizers. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). Single dose ampuls and vial contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide type.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

OB GYN PROCEDURE KIT 
obstetrical kit kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:24840-1711

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:24840-1711-2	10 in 1 CASE
1	NHRIC:24840-1711-1	1 in 1 PACKAGE, COMBINATION

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 AMPULE	5 mL

Part 1 of 1

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 
lidocaine hydrochloride anhydrous and epinephrine injection, solution

Product Information
Item Code (Source)	NDC: 0409-1209
Route of Administration	EPIDURAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	15 mg  in 1 mL
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	5 ug  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)	6.5 mg  in 1 mL
SODIUM METABISULFITE (UNII: 4VON5FNS3C)	0.5 mg  in 1 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	0.2 mg  in 1 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0409-1209-01	5 mL in 1 AMPULE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA088571	04/05/2010

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

Labeler - Centurion Medical Products (017246562)

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

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Hospira Inc		093132819	manufacture