NDC 63323-482

Xylocaine

Lidocaine Hydrochloride,epinephrine Bitartrate

Xylocaine is a Infiltration; Perineural Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Lidocaine Hydrochloride Anhydrous; Epinephrine Bitartrate.

Product ID63323-482_08804def-63df-4817-a638-e46c860266f1
NDC63323-482
Product TypeHuman Prescription Drug
Proprietary NameXylocaine
Generic NameLidocaine Hydrochloride,epinephrine Bitartrate
Dosage FormInjection, Solution
Route of AdministrationINFILTRATION; PERINEURAL
Marketing Start Date2010-08-12
Marketing CategoryNDA / NDA
Application NumberNDA006488
Labeler NameFresenius Kabi USA, LLC
Substance NameLIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE
Active Ingredient Strength10 mg/mL; mg/mL
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63323-482-17

25 VIAL, MULTI-DOSE in 1 TRAY (63323-482-17) > 10 mL in 1 VIAL, MULTI-DOSE (63323-482-01)
Marketing Start Date2010-08-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-482-26 [63323048226]

Xylocaine INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA006488
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-08-12

NDC 63323-482-17 [63323048217]

Xylocaine INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA006488
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-08-12

NDC 63323-482-03 [63323048203]

Xylocaine INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA006488
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-06-07

NDC 63323-482-10 [63323048210]

Xylocaine INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA006488
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-08-12
Marketing End Date2011-06-06

NDC 63323-482-41 [63323048241]

Xylocaine INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA006488
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-07

NDC 63323-482-50 [63323048250]

Xylocaine INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA006488
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-08-12
Marketing End Date2011-06-06

NDC 63323-482-27 [63323048227]

Xylocaine INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA006488
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-08-12

NDC 63323-482-20 [63323048220]

Xylocaine INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA006488
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-08-12
Marketing End Date2011-06-06

NDC 63323-482-05 [63323048205]

Xylocaine INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA006488
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-06-07

NDC 63323-482-01 [63323048201]

Xylocaine INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA006488
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-06-07

NDC 63323-482-57 [63323048257]

Xylocaine INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA006488
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-08-12

Drug Details

Active Ingredients

IngredientStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS10 mg/mL

OpenFDA Data

SPL SET ID:ba082c2f-64f4-419d-9c88-74f203316e17
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1010035
  • 1010033
  • 1867993
  • 1010745
  • 1867997
  • 1867996
  • 1010688
  • 1010749
  • 1010671
  • 1868028
  • 1868029
  • 1737562
  • 1737563
  • 1010673
  • 1737566
  • 1737567
  • 1867992
  • 1867944
  • 1737568
  • 1737569
  • 1010902
  • 1010900
  • 1737570
  • 1010759
  • 1010755
  • 1737345
  • 1737343
  • 1010751
  • 1737758
  • 1010692
  • 1737757
  • 1867938
  • 1867940
  • 1737761
  • 1737762
  • 1737571
  • 1010763
  • 1867943
    • UPC Code
  • 0363323484576
  • 0363323491574

    • Pharmacological Class

    • Amide Local Anesthetic [EPC]
    • Amides [CS]
    • Antiarrhythmic [EPC]
    • Local Anesthesia [PE]
    • Adrenergic alpha-Agonists [MoA]
    • Adrenergic beta-Agonists [MoA]
    • alpha-Adrenergic Agonist [EPC]
    • beta-Adrenergic Agonist [EPC]
    • Catecholamine [EPC]
    • Catecholamines [CS]

    NDC Crossover Matching brand name "Xylocaine" or generic name "Lidocaine Hydrochloride,epinephrine Bitartrate"

    NDCBrand NameGeneric Name
    0404-9972XylocaineLidocaine Hydrochloride and epinephrine
    0404-9973XylocaineLidocaine Hydrochloride
    0404-9974XylocaineLidocaine HCl
    0404-9975XylocaineLidocaine hydrochloride, epinephrine bitartrate injection, solution
    0404-9976XylocaineLidocaine Hydrochloride and epinephrine
    0404-9977XylocaineLidocaine Hydrochloride and Epinephrine
    21695-466XYLOCAINELidocaine Hydrochloride
    50090-3321XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
    52584-481XylocaineLidocaine hydrochloride, epinephrine bitartrate injection, solution
    52584-482XylocaineLidocaine Hydrochloride and Epinephrine
    52584-483XylocaineLidocaine Hydrochloride and epinephrine
    52584-484XylocaineLidocaine Hydrochloride
    52584-485XylocaineLidocaine Hydrochloride
    52584-486XylocaineLidocaine HCl
    70518-0078XylocaineXylocaine
    76478-479XylocaineXylocaine
    52584-489XylocaineXylocaine
    55154-9566XylocaineXylocaine
    55154-9574XylocaineXylocaine
    55154-9572XylocaineXylocaine
    55154-9567XylocaineXylocaine
    55154-9569XylocaineXylocaine
    55154-9575XylocaineXylocaine
    63323-482XylocaineXylocaine
    63323-485XylocaineXylocaine
    63323-486XylocaineXylocaine
    63323-483XylocaineXylocaine
    63323-481XylocaineXylocaine
    63323-484XylocaineXylocaine
    66312-176XylocaineXylocaine
    66312-181XylocaineXylocaine
    70518-2050XylocaineXylocaine
    70518-2049XylocaineXylocaine

    Trademark Results [Xylocaine]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XYLOCAINE
    XYLOCAINE
    72052551 0692703 Live/Registered
    ASTRA PHARMACEUTICAL PRODUCTS, INC.
    1958-05-29
    XYLOCAINE
    XYLOCAINE
    71562437 0534232 Live/Registered
    AKTIEBOLAGET ASTRA, APOTEKARNES KEMISKAFABRIKER
    1948-07-29
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.