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 ID: 42747-604_3ddd489d-750a-4140-b2e2-de649564ed42
• NDC: 42747-604
• Product Type: Human Prescription Drug
• Proprietary Name: NOURIANZ
• Generic Name: Istradefylline
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-08-27
• Marketing Category: NDA / NDA
• Application Number: NDA022075
• Labeler Name: Kyowa Kirin, Inc.
• Substance Name: ISTRADEFYLLINE
• Active Ingredient Strength: 40 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 42747-604-07

1 BLISTER PACK in 1 BOX (42747-604-07) > 7 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2019-08-27
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 42747-604-07 [42747060407]

NOURIANZ TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022075
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-08-27

NDC 42747-604-90 [42747060490]

NOURIANZ TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022075
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-08-27

Drug Details

Active Ingredients

Ingredient	Strength
ISTRADEFYLLINE	40 mg/1

OpenFDA Data

• SPL SET ID: a7d008cb-b273-4049-a5d2-9c6902910d58
• Manufacturer:
  • Kyowa Kirin, Inc.
• UNII:
  • 2GZ0LIK7T4
• RxNorm Concept Unique ID - RxCUI:
  • 2199020
  • 2199026
  • 2199028
  • 2199030
• UPC Code:
  • 0342747602902
  • 0342747604906

NDC Crossover Matching brand name "NOURIANZ" or generic name "Istradefylline"

NDC	Brand Name	Generic Name
42747-602	NOURIANZ	istradefylline
42747-604	NOURIANZ	istradefylline