NDC 50090-4102

Xofluza

Baloxavir Marboxil

Xofluza is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Baloxavir Marboxil.

Product ID50090-4102_70777ca8-f814-4874-9b8b-c1cb5693d1df
NDC50090-4102
Product TypeHuman Prescription Drug
Proprietary NameXofluza
Generic NameBaloxavir Marboxil
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-10-24
Marketing CategoryNDA / NDA
Application NumberNDA210854
Labeler NameA-S Medication Solutions
Substance NameBALOXAVIR MARBOXIL
Active Ingredient Strength20 mg/1
Pharm ClassesPolymerase Acidic Endonuclease Inhibitor [EPC],Polymerase Acidic Endonuclease Inhibitors [MoA],Chelating Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50090-4102-0

1 BLISTER PACK in 1 CARTON (50090-4102-0) > 2 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2019-01-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-4102-0 [50090410200]

Xofluza TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA210854
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-29

Drug Details

Active Ingredients

IngredientStrength
BALOXAVIR MARBOXIL20 mg/1

OpenFDA Data

SPL SET ID:e9e6990a-66d3-4e13-b823-ff04d2d65886
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2100024
  • 2100000
  • 2100099
  • 2100006
  • NDC Crossover Matching brand name "Xofluza" or generic name "Baloxavir Marboxil"

    NDCBrand NameGeneric Name
    50090-4102XofluzaBALOXAVIR MARBOXIL
    50090-4104XofluzaBALOXAVIR MARBOXIL
    50242-583XofluzaBALOXAVIR MARBOXIL
    50242-828XofluzaBALOXAVIR MARBOXIL
    50242-860XofluzaBALOXAVIR MARBOXIL
    50242-877XofluzaBALOXAVIR MARBOXIL

    Trademark Results [Xofluza]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XOFLUZA
    XOFLUZA
    90777855 not registered Live/Pending
    Genentech, Inc.
    2021-06-16
    XOFLUZA
    XOFLUZA
    87920532 not registered Live/Pending
    Genentech, Inc.
    2018-05-14
    XOFLUZA
    XOFLUZA
    87762294 not registered Live/Pending
    Shionogi & Co., Ltd.
    2018-01-19

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