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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 219136

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NDA 219136 describes PROPARACAINE HYDROCHLORIDE, which is a drug marketed by Bausch And Lomb, Mankind Pharma, Micro Labs, Rising, Sola Barnes Hind, and Somerset Theraps Llc, and is included in seven NDAs. It is available from six suppliers. Additional details are available on the PROPARACAINE HYDROCHLORIDE profile page.

The generic ingredient in PROPARACAINE HYDROCHLORIDE is proparacaine hydrochloride. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the proparacaine hydrochloride profile page.

Summary for 219136

Tradename:	PROPARACAINE HYDROCHLORIDE
Applicant:	Mankind Pharma
Ingredient:	proparacaine hydrochloride
Patents:	0

Pharmacology for NDA: 219136

Physiological Effect	Local Anesthesia

Suppliers and Packaging for NDA: 219136

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROPARACAINE HYDROCHLORIDE	proparacaine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	219136	ANDA	Lifestar Pharma LLC	70756-193	70756-193-35	1 BOTTLE, DROPPER in 1 CARTON (70756-193-35) / 15 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.5%
Approval Date:	May 21, 2025	TE:	AT	RLD:	No

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