Xylocaine

Product NDC
52584-486
11-digit product format
525840486
Labeler code
52584
Product ID
52584-486_905cfe2e-c4ce-47b7-a091-1ec3fcfff13b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine HCl
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
General Injectables & Vaccines, Inc
Application
NDA006488
Marketing category
NDA
Marketing start
2011-11-09
Marketing end
2026-01-31
Substance
LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength
20 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPXYLOCAINE (LIDOCAINE HCL) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]3
LIDOCAINEACTIVE MOIETY98PI200987XYLOCAINE (LIDOCAINE HCL) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52584-486XYLOCAINE (LIDOCAINE HCL) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]14Legacy NDC20221223_5bb99cd0-a9e6-4df6-a694-a27430c8f996.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52584-486-27525840486271 VIAL in 1 BAG (52584-486-27) > 20 mL in 1 VIAL1 vial2011-11-090000-00-00NoNoCurrent
52584-486-57525840486571 VIAL in 1 BAG (52584-486-57) > 50 mL in 1 VIAL1 vial2011-11-090000-00-00NoNoCurrent