NDC 62856-290

Fycompa

Perampanel

Fycompa is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Eisai Inc.. The primary component is Perampanel.

Product ID62856-290_0e7ec4cb-8bf0-4c97-8574-7c69b75dea0a
NDC62856-290
Product TypeHuman Prescription Drug
Proprietary NameFycompa
Generic NamePerampanel
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2016-04-30
Marketing CategoryNDA / NDA
Application NumberNDA208277
Labeler NameEisai Inc.
Substance NamePERAMPANEL
Active Ingredient Strength1 mg/mL
Pharm ClassesNoncompetitive AMPA Glutamate Receptor Antagonist [EPC],AMPA Receptor Antagonists [MoA],UGT2B7 Inhibitors [MoA],UGT1A9 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 62856-290-38

340 mL in 1 BOTTLE (62856-290-38)
Marketing Start Date2016-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62856-290-38 [62856029038]

Fycompa SUSPENSION
Marketing CategoryNDA
Application NumberNDA208277
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-04-30

Drug Details

Active Ingredients

IngredientStrength
PERAMPANEL.5 mg/mL

OpenFDA Data

SPL SET ID:71cf3309-e182-473c-8b0b-280cabd0e122
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1356563
  • 1356570
  • 1356572
  • 1356582
  • 1356574
  • 1356584
  • 1356576
  • 1356580
  • 1356578
  • 1356588
  • 1356586
  • 1356557
  • 1790122
  • 1790126
  • UPC Code
  • 0362856243902
  • Pharmacological Class

    • Noncompetitive AMPA Glutamate Receptor Antagonist [EPC]
    • AMPA Receptor Antagonists [MoA]

    NDC Crossover Matching brand name "Fycompa" or generic name "Perampanel"

    NDCBrand NameGeneric Name
    62856-272Fycompaperampanel
    62856-274Fycompaperampanel
    62856-276Fycompaperampanel
    62856-278Fycompaperampanel
    62856-280Fycompaperampanel
    62856-290FycompaFycompa
    62856-282FycompaFycompa

    Trademark Results [Fycompa]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FYCOMPA
    FYCOMPA
    86018781 4530970 Live/Registered
    Eisai R&D Management Co., Ltd.
    2013-07-24
    FYCOMPA
    FYCOMPA
    86018771 4530969 Live/Registered
    Eisai R&D Management Co., Ltd.
    2013-07-24
    FYCOMPA
    FYCOMPA
    85227848 4526076 Live/Registered
    Eisai R&D Management Co., Ltd.
    2011-01-27

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