MedPath
FDA Product

Xylocaine

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Xylocaine

0404-9976

Regulatory Information

0404-9976

NDA006488

C73594

November 15, 2023

USA

Xylocaine(lidocaine HCl Injection, USP) Xylocaine (lidocaine HCl and epinephrine Injection, USP) For Infiltration and Nerve Block

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

Henry Schein, Inc.

012430880

Active Ingredients

EPINEPHRINE BITARTRATE

Quantity: 0.01 mg in 1 mL

Code: 30Q7KI53AK

Class Code: ACTIM

LIDOCAINE HYDROCHLORIDE ANHYDROUS

Quantity: 20 mg in 1 mL

Code: EC2CNF7XFP

Class Code: ACTIB

Active Moieties

EPINEPHRINE

Code: YKH834O4BH

LIDOCAINE

Code: 98PI200987

© Copyright 2025. All Rights Reserved by MedPath