vyloy

Generic: zolbetuximab

Labeler: astellas pharma us, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name vyloy
Generic Name zolbetuximab
Labeler astellas pharma us, inc.
Dosage Form INJECTION, POWDER, FOR SUSPENSION
Routes
INTRAVENOUS
Active Ingredients

zolbetuximab 20 mg/mL

Manufacturer
Astellas Pharma US, Inc.

Identifiers & Regulatory

Product NDC 0469-3425
Product ID 0469-3425_eec900c3-1365-4353-836e-c5e483e43f6a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761365
Listing Expiration 2026-12-31
Marketing Start 2024-10-24

Pharmacologic Class

Established (EPC)
claudin 18.2-directed cytolytic antibody [epc]
Mechanism of Action
claudin 18.2-directed antibody interactions [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04693425
Hyphenated Format 0469-3425

Supplemental Identifiers

RxCUI
2695876 2695882 2710430 2710432
UNII
TF5MPQ8WGY
NUI
N0000194107 N0000194106

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 vyloy (source: ndc)
Generic Name zolbetuximab (source: ndc)
Application Number BLA761365 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 BOX (0469-3425-10) / 5 mL in 1 VIAL
source: ndc

Packages (1)

0469-3425-10 1 VIAL in 1 BOX (0469-3425-10) / 5 mL in 1 VIAL

Ingredients (1)

zolbetuximab (20 mg/mL)

Linked Drug Pages (1)

VYLOY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "eec900c3-1365-4353-836e-c5e483e43f6a", "openfda": {"nui": ["N0000194107", "N0000194106"], "unii": ["TF5MPQ8WGY"], "rxcui": ["2695876", "2695882", "2710430", "2710432"], "spl_set_id": ["e7695a21-abb6-47ac-93f8-0ece5a9c4409"], "pharm_class_epc": ["Claudin 18.2-directed Cytolytic Antibody [EPC]"], "pharm_class_moa": ["Claudin 18.2-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Astellas Pharma US, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX (0469-3425-10)  / 5 mL in 1 VIAL", "package_ndc": "0469-3425-10", "marketing_start_date": "20241024"}], "brand_name": "VYLOY", "product_id": "0469-3425_eec900c3-1365-4353-836e-c5e483e43f6a", "dosage_form": "INJECTION, POWDER, FOR SUSPENSION", "pharm_class": ["Claudin 18.2-directed Antibody Interactions [MoA]", "Claudin 18.2-directed Cytolytic Antibody [EPC]"], "product_ndc": "0469-3425", "generic_name": "ZOLBETUXIMAB", "labeler_name": "Astellas Pharma US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VYLOY", "active_ingredients": [{"name": "ZOLBETUXIMAB", "strength": "20 mg/mL"}], "application_number": "BLA761365", "marketing_category": "BLA", "marketing_start_date": "20241024", "listing_expiration_date": "20261231"}