Details for New Drug Application (NDA): 083158

NDA 083158 describes LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%, which is a drug marketed by Hospira and is included in two NDAs. It is available from three suppliers. Additional details are available on the LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% profile page.

The generic ingredient in LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.

Summary for 083158

Tradename:	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%
Applicant:	Hospira
Ingredient:	lidocaine hydrochloride
Patents:	0

Pharmacology for NDA: 083158

Physiological Effect

Local Anesthesia

Suppliers and Packaging for NDA: 083158

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	083158	ANDA	HF Acquisition Co. LLC, DBA Health First	51662-1230	51662-1230-1	1 SYRINGE, PLASTIC in 1 CARTON (51662-1230-1) / 5 mL in 1 SYRINGE, PLASTIC
LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	083158	ANDA	HF Acquisition Co. LLC, DBA Health First	51662-1230	51662-1230-3	10 POUCH in 1 CASE (51662-1230-3) / 1 SYRINGE in 1 POUCH (51662-1230-2) / 5 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1%
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2%
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	20%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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