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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 213923

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NDA 213923 describes LIDOCAINE AND PRILOCAINE, which is a drug marketed by Alembic, Chartwell Rx, Encube, Fougera Pharms, Hikma, Padagis Us, Pai Holdings Pharm, and Zydus Lifesciences, and is included in eight NDAs. It is available from fourteen suppliers. Additional details are available on the LIDOCAINE AND PRILOCAINE profile page.

The generic ingredient in LIDOCAINE AND PRILOCAINE is lidocaine; prilocaine. There are twenty-nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the lidocaine; prilocaine profile page.

Summary for 213923

Tradename:	LIDOCAINE AND PRILOCAINE
Applicant:	Alembic
Ingredient:	lidocaine; prilocaine
Patents:	0

Pharmacology for NDA: 213923

Physiological Effect	Local Anesthesia

Suppliers and Packaging for NDA: 213923

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LIDOCAINE AND PRILOCAINE	lidocaine; prilocaine	CREAM;TOPICAL	213923	ANDA	Alembic Pharmaceuticals Limited	46708-582	46708-582-04	1 TUBE in 1 CARTON (46708-582-04) / 5 g in 1 TUBE
LIDOCAINE AND PRILOCAINE	lidocaine; prilocaine	CREAM;TOPICAL	213923	ANDA	Alembic Pharmaceuticals Limited	46708-582	46708-582-31	1 TUBE in 1 CARTON (46708-582-31) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	2.5%;2.5%
Approval Date:	Apr 8, 2022	TE:	AB	RLD:	No

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