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FDA Product

XYLOCAINE-MPF WITH EPI

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

Basic Information

XYLOCAINE-MPF WITH EPI

51662-1550

Regulatory Information

51662-1550

NDA006488

C73594

July 14, 2022

USA

XYLOCAINE® -MPF WITH EPI 1:200,000 2% 400mg/20mL (20mg/mL)

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

HF Acquisition Co LLC, DBA HealthFirst

045657305

Active Ingredients

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

SODIUM METABISULFITE

Quantity: 0.5 mg in 1 mL

Code: 4VON5FNS3C

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

EPINEPHRINE BITARTRATE

Quantity: 0.005 mg in 1 mL

Code: 30Q7KI53AK

Class Code: ACTIM

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

LIDOCAINE HYDROCHLORIDE ANHYDROUS

Quantity: 20 mg in 1 mL

Code: EC2CNF7XFP

Class Code: ACTIB

Active Moieties

EPINEPHRINE

Code: YKH834O4BH

BISULFITE ION

Code: OJ9787WBLU

LIDOCAINE

Code: 98PI200987

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