nourianz

Generic: istradefylline

Labeler: kyowa kirin, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nourianz
Generic Name istradefylline
Labeler kyowa kirin, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

istradefylline 40 mg/1

Manufacturer
Kyowa Kirin, Inc.

Identifiers & Regulatory

Product NDC 42747-604
Product ID 42747-604_607b4223-661d-45e0-8209-99c5ba62d5c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022075
Listing Expiration 2026-12-31
Marketing Start 2019-08-27

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42747604
Hyphenated Format 42747-604

Supplemental Identifiers

RxCUI
2199020 2199026 2199028 2199030
UPC
0342747604906 0342747602902
UNII
2GZ0LIK7T4

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nourianz (source: ndc)
Generic Name istradefylline (source: ndc)
Application Number NDA022075 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 BOX (42747-604-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK
  • 90 TABLET, FILM COATED in 1 BOTTLE (42747-604-90)
source: ndc

Packages (2)

42747-604-07 1 BLISTER PACK in 1 BOX (42747-604-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK 42747-604-90 90 TABLET, FILM COATED in 1 BOTTLE (42747-604-90)

Ingredients (1)

istradefylline (40 mg/1)

Linked Drug Pages (1)

NOURIANZ ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "607b4223-661d-45e0-8209-99c5ba62d5c0", "openfda": {"upc": ["0342747604906", "0342747602902"], "unii": ["2GZ0LIK7T4"], "rxcui": ["2199020", "2199026", "2199028", "2199030"], "spl_set_id": ["a7d008cb-b273-4049-a5d2-9c6902910d58"], "manufacturer_name": ["Kyowa Kirin, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BLISTER PACK in 1 BOX (42747-604-07)  / 7 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "42747-604-07", "marketing_start_date": "20190827"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (42747-604-90)", "package_ndc": "42747-604-90", "marketing_start_date": "20190827"}], "brand_name": "NOURIANZ", "product_id": "42747-604_607b4223-661d-45e0-8209-99c5ba62d5c0", "dosage_form": "TABLET, FILM COATED", "product_ndc": "42747-604", "generic_name": "istradefylline", "labeler_name": "Kyowa Kirin, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NOURIANZ", "active_ingredients": [{"name": "ISTRADEFYLLINE", "strength": "40 mg/1"}], "application_number": "NDA022075", "marketing_category": "NDA", "marketing_start_date": "20190827", "listing_expiration_date": "20261231"}