wayrilz

Generic: rilzabrutinib

Labeler: genzyme corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name wayrilz
Generic Name rilzabrutinib
Labeler genzyme corporation
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rilzabrutinib 400 mg/1

Manufacturer
Genzyme Corporation

Identifiers & Regulatory

Product NDC 58468-0251
Product ID 58468-0251_aa3b7d8a-0e0d-481b-bd36-4befaceba422
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA219685
Listing Expiration 2026-12-31
Marketing Start 2025-08-29

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
bruton's tyrosine kinase inhibitors [moa] cytochrome p450 3a inhibitors [moa] p-glycoprotein inhibitors [moa] breast cancer resistance protein inhibitors [moa] organic anion transporting polypeptide 1b1 inhibitors [moa] organic anion transporting polypeptide 1b3 inhibitors [moa] bile salt export pump inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 584680251
Hyphenated Format 58468-0251

Supplemental Identifiers

RxCUI
2722403 2722409
UNII
NWN58M4F5T
NUI
N0000175605 N0000193934 N0000190114 N0000185503 N0000190113 N0000190107 N0000190108 N0000193845

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 wayrilz (source: ndc)
Generic Name rilzabrutinib (source: ndc)
Application Number NDA219685 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (58468-0251-5) / 28 TABLET, FILM COATED in 1 BLISTER PACK (58468-0251-0)
  • 1 BOTTLE in 1 CARTON (58468-0251-6) / 60 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

58468-0251-5 2 BLISTER PACK in 1 CARTON (58468-0251-5) / 28 TABLET, FILM COATED in 1 BLISTER PACK (58468-0251-0) 58468-0251-6 1 BOTTLE in 1 CARTON (58468-0251-6) / 60 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

rilzabrutinib (400 mg/1)

Linked Drug Pages (1)

WAYRILZ ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "aa3b7d8a-0e0d-481b-bd36-4befaceba422", "openfda": {"nui": ["N0000175605", "N0000193934", "N0000190114", "N0000185503", "N0000190113", "N0000190107", "N0000190108", "N0000193845"], "unii": ["NWN58M4F5T"], "rxcui": ["2722403", "2722409"], "spl_set_id": ["95ffd367-9b0c-4f75-8487-5d8f3c0a5ad0"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Bruton's Tyrosine Kinase Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]", "Bile Salt Export Pump Inhibitors [MoA]"], "manufacturer_name": ["Genzyme Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (58468-0251-5)  / 28 TABLET, FILM COATED in 1 BLISTER PACK (58468-0251-0)", "package_ndc": "58468-0251-5", "marketing_start_date": "20250829"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58468-0251-6)  / 60 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58468-0251-6", "marketing_start_date": "20250829"}], "brand_name": "WAYRILZ", "product_id": "58468-0251_aa3b7d8a-0e0d-481b-bd36-4befaceba422", "dosage_form": "TABLET, FILM COATED", "product_ndc": "58468-0251", "generic_name": "rilzabrutinib", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "WAYRILZ", "active_ingredients": [{"name": "RILZABRUTINIB", "strength": "400 mg/1"}], "application_number": "NDA219685", "marketing_category": "NDA", "marketing_start_date": "20250829", "listing_expiration_date": "20261231"}