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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 083173

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NDA 083173 describes LIDOCAINE HYDROCHLORIDE, which is a drug marketed by Abbott, Abraxis Pharm, Afaxys, Am Regent, Aspiro, B Braun Medical, Bel Mar, Belmora Llc, Dell Labs, Elkins Sinn, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Huons, Intl Medication, Luitpold, Lyphomed, Mankind Pharma, Miles, Neocubes Pharma, Rising, Spectra Mdcl Devices, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Yiling, Cosette, Sentiss, Watson Labs Inc, Aurobindo Pharma Ltd, Hikma, Pharmobedient, Rubicon Research, Lannett Co Inc, Novitium Pharma, Paco, Pai Holdings Pharm, Sun Pharma Canada, The J Molner, Baxter Hlthcare, B Braun, Eastman Kodak, Empi, Extrovis, Actavis Mid Atlantic, and Chartwell Molecular, and is included in one hundred and eleven NDAs. It is available from forty-seven suppliers. Additional details are available on the LIDOCAINE HYDROCHLORIDE profile page.

The generic ingredient in LIDOCAINE HYDROCHLORIDE is epinephrine; lidocaine hydrochloride. There are twenty-one drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.

Summary for 083173

Tradename:	LIDOCAINE HYDROCHLORIDE
Applicant:	Intl Medication
Ingredient:	lidocaine hydrochloride
Patents:	0

Pharmacology for NDA: 083173

Physiological Effect	Local Anesthesia

Suppliers and Packaging for NDA: 083173

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	083173	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1382	51662-1382-3	10 POUCH in 1 CASE (51662-1382-3) / 1 CARTON in 1 POUCH (51662-1382-2) / 1 SYRINGE in 1 CARTON (51662-1382-1) / 5 mL in 1 SYRINGE
LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	083173	ANDA	REMEDYREPACK INC.	70518-4176	70518-4176-0	10 SYRINGE in 1 PACKAGE (70518-4176-0) / 5 mL in 1 SYRINGE (70518-4176-1)

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:	No

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