MedPath
FDA Product

Xylocaine

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

Basic Information

Xylocaine

50090-6851

Regulatory Information

50090-6851

NDA006488

C73594

August 28, 2020

USA

Xylocaine® (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP)

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

830016429

Active Ingredients

SODIUM METABISULFITE

Quantity: 0.5 mg in 1 mL

Code: 4VON5FNS3C

Class Code: IACT

SODIUM CHLORIDE

Quantity: 6 mg in 1 mL

Code: 451W47IQ8X

Class Code: IACT

CITRIC ACID MONOHYDRATE

Quantity: 0.2 mg in 1 mL

Code: 2968PHW8QP

Class Code: IACT

METHYLPARABEN

Quantity: 1 mg in 1 mL

Code: A2I8C7HI9T

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

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

LIDOCAINE

Code: 98PI200987

EPINEPHRINE

Code: YKH834O4BH

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