NDC product

VYLOY

NDC 0469-4425 · Astellas Pharma US, Inc.

Key facts

Product NDC 0469-4425
Proprietary name VYLOY
Nonproprietary name ZOLBETUXIMAB
Substances ZOLBETUXIMAB
Dosage form INJECTION, POWDER, FOR SUSPENSION
Route INTRAVENOUS
Labeler Astellas Pharma US, Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category BLA
Application number BLA761365
Pharmacologic classes Claudin 18.2-directed Antibody Interactions [MoA], Claudin 18.2-directed Cytolytic Antibody [EPC]
Marketing start Apr 24, 2025
Listing certified through Dec 31, 2027

At a glance

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About National Drug Codes (NDC)

The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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