FDA Product

Xylocaine

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

Basic Information

Product Name

Xylocaine

FDA Product Code

52584-485

Regulatory Information

NDC Product Code

52584-485

Application Number

NDA006488

Marketing Category

C73594

Effective Date

December 22, 2022

Territorial Authority

USA

FDA Title

Xylocaine 1% (10mg/mL)

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

8

Company Information

ManufacturerGeneral Injectables and Vaccines, inc.

DUNS Number

108250663

Active Ingredients

LIDOCAINE HYDROCHLORIDE ANHYDROUS

Quantity: 10 mg in 1 mL

Code: EC2CNF7XFP

Class Code: ACTIB

Active Moieties

LIDOCAINE

Code: 98PI200987

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