Package 0469-3425-10

Brand: vyloy

Generic: zolbetuximab
NDC Package

Package Facts

Identity

Package NDC 0469-3425-10
Digits Only 0469342510
Product NDC 0469-3425
Product ID 0469-3425_eec900c3-1365-4353-836e-c5e483e43f6a
Description

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

Marketing

Marketing Status
Marketed Since 2024-10-24
Brand vyloy
Generic zolbetuximab
Sample Package No

Linked Drug Pages (1)

VYLOY ndc-match (0.95)

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"}