NDC 63323-488

Xylocaine MPF

Lidocaine Hydrochloride,epinephrine Bitartrate

Xylocaine MPF is a Epidural; Infiltration; Intracaudal; 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 ID63323-488_08804def-63df-4817-a638-e46c860266f1
NDC63323-488
Product TypeHuman Prescription Drug
Proprietary NameXylocaine MPF
Generic NameLidocaine Hydrochloride,epinephrine Bitartrate
Dosage FormInjection, Solution
Route of AdministrationEPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Marketing Start Date2010-08-12
Marketing CategoryNDA / NDA
Application NumberNDA006488
Labeler NameFresenius Kabi USA, LLC
Substance NameLIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE
Active Ingredient Strength15 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 63323-488-17

25 VIAL, SINGLE-DOSE in 1 TRAY (63323-488-17) > 10 mL in 1 VIAL, SINGLE-DOSE (63323-488-01)
Marketing Start Date2010-08-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-488-03 [63323048803]

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

NDC 63323-488-01 [63323048801]

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

NDC 63323-488-31 [63323048831]

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

NDC 63323-488-37 [63323048837]

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

NDC 63323-488-17 [63323048817]

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

NDC 63323-488-10 [63323048810]

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

NDC 63323-488-07 [63323048807]

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

NDC 63323-488-30 [63323048830]

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

NDC 63323-488-92 [63323048892]

Xylocaine MPF INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA006488
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-08-12
Marketing End Date2015-01-28

Drug Details

Active Ingredients

IngredientStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS15 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 MPF" or generic name "Lidocaine Hydrochloride,epinephrine Bitartrate"

    NDCBrand NameGeneric Name
    70518-1600Xylocaine MPFXylocaine MPF
    55154-9573Xylocaine MPFXylocaine MPF
    55154-9388Xylocaine MPFXylocaine MPF
    55154-9396Xylocaine MPFXylocaine MPF
    63323-495Xylocaine MPFXylocaine MPF
    63323-491Xylocaine MPFXylocaine MPF
    63323-492Xylocaine MPFXylocaine MPF
    63323-487Xylocaine MPFXylocaine MPF
    63323-496Xylocaine MPFXylocaine MPF
    63323-493Xylocaine MPFXylocaine MPF
    65219-812Xylocaine MPFXylocaine MPF
    65219-814Xylocaine MPFXylocaine MPF
    65219-810Xylocaine MPFXylocaine MPF
    50090-3321XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
    55154-9566XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
    55154-9567XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
    55154-9568XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
    55154-9575XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
    63323-481XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
    63323-482XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
    63323-483XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
    63323-488XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
    63323-489XylocaineLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE

    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
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