Last Updated: May 25, 2026

Details for New Drug Application (NDA): 040433

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NDA 040433 describes LIDOCAINE HYDROCHLORIDE, which is a drug marketed by Abbott, Abraxis Pharm, Afaxys, Am Regent, Anthea Pharma, 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, Rising, Spectra Mdcl Devices, Viwit Pharm, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Yiling, Cosette, Sentiss, Watson Labs Inc, Aurobindo Pharma Ltd, Hikma, Pharmobedient, Quagen, 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 thirteen NDAs. It is available from forty-five 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. Thirteen suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.

Summary for 040433

Tradename:	LIDOCAINE HYDROCHLORIDE
Applicant:	Sentiss
Ingredient:	lidocaine hydrochloride
Patents:	0

Pharmacology for NDA: 040433

Physiological Effect	Local Anesthesia

Suppliers and Packaging for NDA: 040433

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	JELLY;TOPICAL	040433	ANDA	ARMAS PHARMACEUTICALS INC.	72485-611	72485-611-10	1 TUBE in 1 CARTON (72485-611-10) / 5 mL in 1 TUBE
LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	JELLY;TOPICAL	040433	ANDA	ARMAS PHARMACEUTICALS INC.	72485-611	72485-611-30	1 TUBE, WITH APPLICATOR in 1 CARTON (72485-611-30) / 30 mL in 1 TUBE, WITH APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	JELLY;TOPICAL			Strength	2%
Approval Date:	Feb 12, 2003	TE:	AT	RLD:	No

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