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J1326

J1326 – Inj, zolbetuximab-clzb, 2 mg · NDC Crosswalk & Billing Units

HCPCS Level II J-code · Medicare Part B drug billing
J-code ● 2 NDCs crosswalked per 2 MG $33.924/unit ASP+6%

📋 J1326 summary

J1326 is a HCPCS Level II J-code used to bill zolbetuximab-clzb, 2 mg, billed per 2 MG. The number of billing units to report depends on the dose administered and the NDC/package billed — use the calculator below.

Brand names associated with J1326: Vyloy

Code J1326 Billing unit 2 MG Payment limit $33.924/unit NDC-Crosswalk 2 Quarter Q3 2026 RxCUI Atlas Trace the drug concept →

⚠ An NDC↔HCPCS crosswalk and a published payment limit do not guarantee payer coverage or payment. Always verify the current payer policy and claim format before billing.

🗂️ Key billing facts

HCPCS codeJ1326
DescriptorInj, zolbetuximab-clzb, 2 mg
Billing unit2 MG
Payment limit / unit$33.924
Est. ASP / unit$32.004 est.
Mapped NDCs2
Data periodQ3 2026
Last updated2026-08-20

💊 About Zolbetuximab DRUG GUIDE

Vyloy (zolbetuximab-clzb) is used alongside fluoropyrimidine- and platinum-based chemotherapy as a first-line treatment for adults with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma — meaning stomach or junction-of-stomach-and-esophagus cancer that has spread or cannot be surgically removed.

The cancer must test negative for HER2 and must test positive for a protein called CLDN18.2 (claudin 18.2) using an FDA-approved diagnostic test.Vyloy is always given together with chemotherapy — never on its own — and is intended for adults who have not yet received prior treatment for their advanced cancer.

Read the full Zolbetuximab drug guide →
Clinical overview from our editorial drug guide for Zolbetuximab. For billing reference, see the sections above.

🧾 Billing & reimbursement HCPCS · CMS · EFF. Q3 2026

📅 Payment limits effective Q3 2026 — from the CMS Medicare Part B Payment Limit File (revised quarterly).
Medicare payment limit / unit
$33.924
Est. ASP / unit
$32.004 est.
Est. after 2% sequester
$33.246
HCPCS dosage
2 MG
The CMS payment limit is the Medicare Part B drug allowance (ASP + 6%, statutory). After the 2% federal sequester the effective payment is ≈ ASP + 4.3%; estimated ASP = payment limit ÷ 1.06. Source: CMS Medicare Part B Payment Limit File (quarterly), Q3 2026.

🧮 Dosing & billing-units calculator HCPCS UNITS

One billing unit of J1326 = 2 mg. Enter a regimen to convert dose → billing units and project a full course.
Billing units = dose ÷ HCPCS unit size. Most payers require whole units — round per the payer's policy. “Est. Medicare pay” uses the current payment limit. For single-dose vials, drug discarded after administration may be separately billable with modifier JW (JZ when none is discarded) where allowed. Always verify payer-specific rounding before billing.

🔁 NDCs that bill under J1326 WITH EST. MEDICARE PAY

2 NDCs map to J1326. Bill units = how many HCPCS units one package represents. Est. pay / pkg = payment limit ($33.924/unit) × that package's bill units.
NDC (11-digit)DrugLabelerPackageStrength Bill units Est. pay / pkg NADAC / unit StatusSource
00469-3425-10 VYLOY ZOLBETUXIMAB 20 mg/mL INJECTION, POWDER, FOR SUSPENSION Astellas 1 VIAL in 1 BOX (0469-3425-10) / 5 mL in... 20 mg/mL 50 $1,696.20 ● Active CMS + PDAC
00469-4425-30 VYLOY ZOLBETUXIMAB 20 mg/mL INJECTION, POWDER, FOR SUSPENSION Astellas 1 VIAL in 1 BOX (0469-4425-30) / 15 mL in... 20 mg/mL 150 $5,088.60 ● Active CMS + PDAC
NDC→HCPCS mappings come from the CMS ASP NDC-HCPCS crosswalk; additional DME MAC / DMEPOS mappings come from PDAC and are labeled separately. NADAC from CMS (weekly). “Status” reflects the product's marketing / obsolete flag in the NDC directory. Presence or absence here does not determine Medicare coverage. Linked NDCs open the full product page.

📊 Medicare utilization & spend CMS · PART B · 2026 (Q1)

Period
Total Part B spend
$12.35M
Claims
834
Beneficiaries
278
Spend / beneficiary
$44,423.91
Spend / claim
$14,807.97
Trend by period
Where J1326 ranks among Part B drugs · 2026 (Q1) · neighbors ±5

Full breakdown by period (2)
PeriodTotal spendBeneficiariesClaims$/beneficiary$/claim
2026 (Q1) $12.35M 278 834 $44,423.91 $14,807.97
2025 (Q1-Q4) $21.54M 335 1,343 $64,301.54 $16,039.48
Provider-administered (Part B) spend, calculated for the whole HCPCS code (CMS does not publish Medicare spend per individual NDC). Self-administered use is covered under Part D instead. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part B Spending by Drug (data.cms.gov), updated quarterly.

📈 Medicare Part B claims detail CMS PSPS · 2024

Calendar-year 2024 Medicare Part B fee-for-service activity for this HCPCS code, summed across all carriers, localities and specialties (CMS Physician/Supplier Procedure Summary). A “service” is one billed line/unit — not one claim — so counts run higher than claim counts.
Allowed charges
$7.77M
Medicare paid
$6.1M
Submitted services
252,848
Denial rate
8.6%
Allowed / service
$33.65
Submitted charges
$22.95M
Source: CMS Physician/Supplier Procedure Summary (PSPS), CY2024 — Medicare Part B carrier + DME fee-for-service claims (excludes Medicare Advantage). Figures are for the whole HCPCS code, which may cover uses beyond this drug. ⚠ CMS hides any figure covering fewer than 11 patients (a privacy rule), so totals — especially denials and low-volume codes — run a little low.

📊 What bills under J1326

J-codes are billing codes often used for drugs billed under the medical benefit. This connects the billing code to the NDC package records it covers, by ingredient and labeler.

NDC products by ingredient
ZOLBETUXIMAB 4
NDC products by labeler
Astellas Pharma US, Inc. 4

🗃️ Data sources & freshness

Every figure on this page is computed from public datasets. Here's what each section draws on and how current it is.
HCPCS code & descriptor
CMS HCPCS Level II code file
Not available in current dataset
Payment limit & billing unit
CMS Medicare Part B ASP Pricing File (quarterly)
Q3 2026 · as of 2026-08-20
NDC ↔ HCPCS crosswalk
CMS ASP NDC-HCPCS crosswalk + DMEPDAC (PDAC)
2 NDCs mapped
NADAC acquisition cost
CMS National Average Drug Acquisition Cost (weekly)
Not available for mapped NDCs
Utilization & spend
CMS Part B Spending by Drug · PSPS · Physician & Other Practitioners
Latest data year 2026
Figures are estimates for reference and may lag the source files. Always verify against the current CMS files and your payer's policy before submitting claims.

⚠️ Practical billing caveats

  • A crosswalk is not coverage. An NDC mapping or a published payment limit does not guarantee a payer will cover or pay this code. Check the specific plan's policy.
  • Units ≠ milligrams. Bill the number of HCPCS units (dose ÷ the code's unit size), not the milligram dose. Use the calculator above.
  • Discarded drug. For single-dose vials, drug discarded after administration may be separately billable with modifier JW (and JZ when nothing is discarded) where the payer allows.
  • Rounding & partial units. Many payers require whole units; round per the payer's policy, not automatically up.
  • The code can cover more than this drug. Some HCPCS codes span multiple products or strengths — confirm the exact code for the product administered.
  • Figures lag. ASP limits change quarterly and utilization data are released with a delay. Verify against the current CMS files before billing.

J1326 billing FAQ

What is HCPCS code J1326?
J1326 is a HCPCS Level II J-code used to bill Inj, zolbetuximab-clzb, 2 mg under Medicare Part B and most medical (not pharmacy) benefits.
What is the billing unit for J1326?
One unit of J1326 represents 2 MG. Report the number of units equal to the dose administered divided by 2 MG.
How many units of J1326 should I bill?
Divide the dose administered by the code's unit size (2 MG) to get the number of billing units, then round per your payer's policy. The calculator on this page converts a dose into billing units and projects a full course.
How much does Medicare pay for J1326?
The Medicare Part B payment limit is $33.924 per unit (Q3 2026), based on ASP + 6%. After the 2% sequester the effective payment is about $33.246 per unit. Payment limits are revised quarterly.
Which NDCs bill under J1326?
2 NDCs currently map to J1326 in the CMS ASP NDC-HCPCS crosswalk. See the NDC crosswalk table above for each product, package, billing units and estimated reimbursement.
Does a crosswalk mean J1326 is covered?
No. An NDC-to-HCPCS crosswalk and a published payment limit do not guarantee coverage or payment. Coverage depends on the payer, the diagnosis and the site of care — always verify the current policy before billing.
For professional billing reference only — verify against the current CMS files before submitting claims.