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United States · US · US:58468-0251_aa3b7d8a-0e0d-481b-bd36-4befaceba422
WAYRILZ
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGenzyme Corporation
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1158468025152 BLISTER PACK in 1 CARTON (58468-0251-5) / 28 TABLET, FILM COATED in 1 BLISTER PACK (58468-0251-0)
- ndc1158468025161 BOTTLE in 1 CARTON (58468-0251-6) / 60 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
NWN58M4F5T
RILZABRUTINIB
Orange Book
N219685
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "NWN58M4F5T",
"rxcui": null,
"inchikey": null,
"display_name": "RILZABRUTINIB",
"substance_type": "mixture",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"95ffd367-9b0c-4f75-8487-5d8f3c0a5ad0": {
"match": "brand_token",
"title": "WAYRILZ (RILZABRUTINIB) TABLET, FILM COATED [GENZYME CORPORATION]",
"spl_version": "6",
"published_date": "2025-09-01"
}
},
"productid": "58468-0251_aa3b7d8a-0e0d-481b-bd36-4befaceba422",
"productndc": "58468-0251",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "219685",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "400MG",
"product_no": "001",
"approval_date": "Aug 29, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RILZABRUTINIB",
"proprietary_name": "WAYRILZ",
"active_ingred_unit": "mg/1",
"application_number": "NDA219685",
"marketing_category": "NDA",
"nonproprietary_name": "rilzabrutinib",
"start_marketing_date": "20250829",
"active_numerator_strength": "400"
}Access this data programmatically
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