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United States · US · US:42747-602_607b4223-661d-45e0-8209-99c5ba62d5c0
NOURIANZ
Orange BookUNIISPLATC N04CX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKyowa Kirin, Inc.
CountryUS (United States)
ATC codeN04CX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1142747602071 BLISTER PACK in 1 BOX (42747-602-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK
- ndc11427476029090 TABLET, FILM COATED in 1 BOTTLE (42747-602-90)
Annotations
UNII (FDA Substance ID)
2GZ0LIK7T4
ISTRADEFYLLINE
RxCUI 2199015
Orange Book
N022075
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2GZ0LIK7T4",
"rxcui": "2199015",
"inchikey": "IQVRBWUUXZMOPW-PKNBQFBNSA-N",
"display_name": "ISTRADEFYLLINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"a7d008cb-b273-4049-a5d2-9c6902910d58": {
"match": "brand_token",
"title": "NOURIANZ (ISTRADEFYLLINE) TABLET, FILM COATED [KYOWA KIRIN, INC.]",
"spl_version": "6",
"published_date": "2025-05-23"
}
},
"productid": "42747-602_607b4223-661d-45e0-8209-99c5ba62d5c0",
"productndc": "42747-602",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "022075",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "20MG",
"product_no": "001",
"approval_date": "Aug 27, 2019"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "40MG",
"product_no": "002",
"approval_date": "Aug 27, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ISTRADEFYLLINE",
"proprietary_name": "NOURIANZ",
"active_ingred_unit": "mg/1",
"application_number": "NDA022075",
"marketing_category": "NDA",
"nonproprietary_name": "istradefylline",
"start_marketing_date": "20190827",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code N04CX01.
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