Xylocaine

Product NDC
52584-482
11-digit product format
525840482
Labeler code
52584
Product ID
52584-482_d26080e1-aa1e-45e8-9cfc-6dfc49bfa495
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride and Epinephrine
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
General Injectables & Vaccines, Inc
Application
NDA006488
Marketing category
NDA
Marketing start
2011-09-12
Marketing end
2023-12-31
Substance
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength
0 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
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52584-482-27525840482271 VIAL in 1 BAG (52584-482-27) > 20 mL in 1 VIAL1 vial2011-09-120000-00-00NoNoCurrent
52584-482-57525840482571 VIAL in 1 BAG (52584-482-57) > 50 mL in 1 VIAL1 vial2011-09-120000-00-00NoNoCurrent