Vyloy Injection, Powder, For Suspension
NDC Package 0469-3425-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Vyloy (zolbetuximab) injection is vYLOY, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)‑negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test [see Dosage and Administration (2.1) and Clinical Studies (14)]. This formulation utilizes a injection, powder, for suspension delivery system. Marketed by Astellas Pharma Us, Inc., this product is identified by NDC 0469-3425 and is authorized under FDA application BLA761365.

Identification & Billing

NDC Package Code
0469-3425-10
Package Description
1 VIAL in 1 BOX / 5 mL in 1 VIAL
Product Code
0469-3425
11-Digit Billing Format
00469342510
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vyloy
Non-Proprietary Name
Zolbetuximab
Substance Name
Zolbetuximab
Dosage Form
Injection, Powder, For Suspension - A sterile preparation intended for reconstitution to form a suspension for parenteral use.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ZOLBETUXIMAB 20 mg/mL
Pharmacologic Class
Usage Information
VYLOY, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)‑negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test [see Dosage and Administration (2.1) and Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Astellas Pharma Us, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761365
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-24-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1326
Source: PDAC
INJECTION, ZOLBETUXIMAB-CLZB, 2 MG
HCPCS Dosage 2 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0469-3425-10 identifies a specific commercial package of 1 vial in 1 box / 5 ml in 1 vial of Vyloy, a human prescription drug labeled by Astellas Pharma Us, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, for suspension is formulated for intravenous use and contains zolbetuximab as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Astellas Pharma Us, Inc. on October 24, 2024. The current certification is valid through December 31, 2026.

How is this Astellas Pharma Us, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00469342510. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0469-3425-10
11-Digit CMS (5-4-2)
00469-3425-10

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.