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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 212821

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NDA 212821 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, 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-six 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. Fourteen suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.

Summary for 212821

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

Pharmacology for NDA: 212821

Physiological Effect	Local Anesthesia

Suppliers and Packaging for NDA: 212821

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	212821	ANDA	McKesson Corporation dba SKY Packaging	63739-170	63739-170-24	10 VIAL in 1 BOX (63739-170-24) / 5 mL in 1 VIAL (63739-170-13)
LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	212821	ANDA	McKesson Corporation dba SKY Packaging	63739-170	63739-170-27	25 VIAL in 1 BOX (63739-170-27) / 5 mL in 1 VIAL (63739-170-13)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1%
Approval Date:	May 7, 2020	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2%
Approval Date:	Jun 15, 2023	TE:	AP	RLD:	No

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