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VYLOY

NDC 0469-4425 · Astellas Pharma US, Inc.

Generic nameZOLBETUXIMAB

Dosage formINJECTION, POWDER, FOR SUSPENSION

RouteINTRAVENOUS

Active ingredient(s)ZOLBETUXIMAB

Strength20 mg/mL

Pharmacologic classClaudin 18.2-directed Antibody Interactions [MoA], Claudin 18.2-directed Cytolytic Antibody [EPC]

Marketing categoryBLA

Packages

0469-4425-30 — 1 VIAL in 1 BOX (0469-4425-30) / 15 mL in 1 VIAL

Billed under HCPCS

J1326 — Injection, zolbetuximab-clzb, 2 mg Medicare Part B payment limit (ASP + 6%): $33.92

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

0469-3425 — ZOLBETUXIMAB

From the FDA National Drug Code Directory, retrieved August 24, 2026. Product listings are submitted by labelers; FDA does not verify them.

Read from: FDA National Drug Code Directory, product.txt and package.txt (accessdata.fda.gov/cder/ndctext.zip) — Snapshot retrieved 2026-08-24, loaded 2026-08-24; CMS Medicare Part B Drug Average Sales Price (ASP) Pricing Files (cms.gov/medicare/payment/part-b-drugs/asp-pricing-files) -- the NDC-HCPCS crosswalk and Part B payment limit files — 2026 Q3 (July 2026 release). All data sources · How to read the labels