NDC 42747-604

NOURIANZ

Istradefylline

NOURIANZ is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Kyowa Kirin, Inc.. The primary component is Istradefylline.

Product ID42747-604_3ddd489d-750a-4140-b2e2-de649564ed42
NDC42747-604
Product TypeHuman Prescription Drug
Proprietary NameNOURIANZ
Generic NameIstradefylline
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-08-27
Marketing CategoryNDA / NDA
Application NumberNDA022075
Labeler NameKyowa Kirin, Inc.
Substance NameISTRADEFYLLINE
Active Ingredient Strength40 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 42747-604-07

1 BLISTER PACK in 1 BOX (42747-604-07) > 7 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2019-08-27
NDC Exclude FlagN
Sample Package?Y

NDC SPL Data Element Entries

NDC 42747-604-07 [42747060407]

NOURIANZ TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022075
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-27

NDC 42747-604-90 [42747060490]

NOURIANZ TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022075
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-27

Drug Details

Active Ingredients

IngredientStrength
ISTRADEFYLLINE40 mg/1

OpenFDA Data

SPL SET ID:a7d008cb-b273-4049-a5d2-9c6902910d58
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2199020
  • 2199026
  • 2199028
  • 2199030
  • UPC Code
  • 0342747602902
  • 0342747604906
  • NDC Crossover Matching brand name "NOURIANZ" or generic name "Istradefylline"

    NDCBrand NameGeneric Name
    42747-602NOURIANZistradefylline
    42747-604NOURIANZistradefylline

    Trademark Results [NOURIANZ]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NOURIANZ
    NOURIANZ
    87086056 not registered Live/Pending
    KYOWA KIRIN CO., LTD.
    2016-06-28

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