Xylocaine

Product NDC
50090-6851
11-digit product format
500906851
Labeler code
50090
Product ID
50090-6851_64eae69a-c01a-49c4-93d1-333b26983809
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
A-S Medication Solutions
Application
NDA006488
Marketing category
NDA
Marketing start
2010-08-12
Substance
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength
.01; 20 mg/mL; mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
30Q7KI53AKEPINEPHRINE BITARTRATE51-42-3EPINEPHRINE BITARTRATE
EC2CNF7XFPLIDOCAINE HYDROCHLORIDE ANHYDROUS73-78-9LIDOCAINE HYDROCHLORIDE ANHYDROUS

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6851-05009068510025 VIAL, MULTI-DOSE in 1 TRAY (50090-6851-0) / 20 mL in 1 VIAL, MULTI-DOSE2023-11-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Xylocaine® (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP)A-S Medication Solutions2023-12-04HUMAN PRESCRIPTION DRUG LABEL1