NDC 52584-489

Xylocaine

Lidocaine Hydrochloride And Epinephrine

Xylocaine is a Epidural; Infiltration; Intracaudal; Perineural Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc. The primary component is Epinephrine Bitartrate; Lidocaine Hydrochloride Anhydrous.

Product ID52584-489_35eab8bc-aff5-4119-8291-cebc47733de5
NDC52584-489
Product TypeHuman Prescription Drug
Proprietary NameXylocaine
Generic NameLidocaine Hydrochloride And Epinephrine
Dosage FormInjection, Solution
Route of AdministrationEPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Marketing Start Date2011-09-27
Marketing End Date2024-03-31
Marketing CategoryNDA / NDA
Application NumberNDA006488
Labeler NameGeneral Injectables & Vaccines, Inc
Substance NameEPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active Ingredient Strength0 mg/mL; mg/mL
Pharm ClassesAdrenergic 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 FlagN

Packaging

NDC 52584-489-27

1 VIAL in 1 BAG (52584-489-27) > 20 mL in 1 VIAL
Marketing Start Date2011-09-27
Marketing End Date2024-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-489-27 [52584048927]

Xylocaine INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA006488
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-09-27

Drug Details

Active Ingredients

IngredientStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg/mL

OpenFDA Data

SPL SET ID:c85e6c03-ca15-4c61-b023-22b0f50cbe9a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1010688
  • 1010692

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Xylocaine" or generic name "Lidocaine Hydrochloride And Epinephrine"

    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
    70518-0078XylocaineXylocaine
    76478-479XylocaineXylocaine
    21695-466XYLOCAINEXYLOCAINE
    52584-489XylocaineXylocaine
    52584-484XylocaineXylocaine
    52584-486XylocaineXylocaine
    52584-485XylocaineXylocaine
    52584-483XylocaineXylocaine
    52584-481XylocaineXylocaine
    52584-482XylocaineXylocaine
    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
    0362-0262LidocaineLidocaine Hydrochloride and Epinephrine
    0362-0898LidocaineLidocaine Hydrochloride and Epinephrine
    0404-9886Lidocaine Hydrochloride and EpinephrineLidocaine Hydrochloride and Epinephrine
    0404-9891Lidocaine Hydrochloride and EpinephrineLidocaine Hydrochloride and Epinephrine
    0404-9896Lidocaine Hydrochloride and EpinephrineLidocaine Hydrochloride and Epinephrine
    0409-1209Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE and EPINEPHRINE
    0409-3177Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE and EPINEPHRINE
    0362-1096Lignospan ForteLidocaine Hydrochloride and Epinephrine
    0362-1095Lignospan StandardLidocaine Hydrochloride and Epinephrine

    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.