Xylocaine

Product NDC
52584-483
11-digit product format
525840483
Labeler code
52584
Product ID
52584-483_27ebda5f-3f7b-4b3d-8dea-46f2a18d8a79
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
2019-07-15
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52584-483-27525840483271 VIAL, MULTI-DOSE in 1 BAG (52584-483-27) > 20 mL in 1 VIAL, MULTI-DOSE2019-07-152023-11-30NoNoCurrent
52584-483-57525840483571 VIAL, MULTI-DOSE in 1 BAG (52584-483-57) > 50 mL in 1 VIAL, MULTI-DOSE2019-07-152023-12-31NoNoCurrent