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J8565

J8565 – Gefitinib, oral, 250 mg · NDC Crosswalk & Billing Units

HCPCS Level II J-code · Medicare Part B drug billing
J-code ● 5 NDCs crosswalked

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

📋 J8565 summary

J8565 is a HCPCS Level II J-code used to bill Gefitinib, oral, 250 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 J8565: Iressa

Code J8565 NDC-Crosswalk 5 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 codeJ8565
DescriptorGefitinib, oral, 250 mg
Billing unitNot available in current dataset
Payment limit / unit Not available in current dataset
Mapped NDCs5
Data periodNot available in current dataset
Last updatedSource date not available

💊 About Gefitinib DRUG GUIDE

Gefitinib tablets, including the brand Iressa, are used as first-line (first treatment) therapy for metastatic non-small cell lung cancer (NSCLC).

This applies only when the tumor has an EGFR exon 19 deletion or an exon 21 (L858R) substitution mutation, found by an FDA-approved test.Safety and effectiveness have not been established for NSCLC with other EGFR mutations.

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

🧾 Billing & reimbursement HCPCS · CMS

Medicare payment limit / unit
—
Est. ASP / unit
—
Est. after 2% sequester
—
HCPCS dosage
—
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).
Full HCPCS code details (official CMS record)
Long descriptionGefitinib, oral, 250 mg
CoverageD — Special coverage instructions apply
Pricing indicator00 — Not separately priced (bundled)
Type of service9 — Other medical items or services
BETOS-2O1E
ASC payment group—
Action codeN — No maintenance this year
Effective date2015-01-01
Date added2005-01-01
Source: CMS HCPCS Level II code file (imported via admin).

🧮 Dosing & billing-units calculator HCPCS UNITS

One billing unit of J8565 = 1 unit. 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 J8565 CROSSWALKED NDCs

5 NDCs map to J8565. Bill units = how many HCPCS units one package represents.
NDC (11-digit)DrugLabelerPackageStrength Bill units NADAC / unit StatusSource
00480-4053-56 Gefitinib 250 mg/1 TABLET, FILM COATED Teva 30 TABLET, FILM COATED in 1 BOTTLE (0480-4... 250 mg/1 1 — ● Active PDAC
69339-0168-03 Gefitinib 250 mg/1 TABLET, FILM COATED Natco 30 TABLET, FILM COATED in 1 BOTTLE (69339-... 250 mg/1 1 — ● Active PDAC
50742-0366-30 Gefitinib 250 mg/1 TABLET, COATED Ingenus 30 TABLET, COATED in 1 BOTTLE (50742-366-3... 250 mg/1 1 — ● Active PDAC
00310-0482-30 IRESSA Gefitinib 250 mg/1 TABLET, COATED AstraZeneca 30 TABLET, COATED in 1 BOTTLE (0310-0482-3... 250 mg/1 1 — ● Active PDAC
60505-4512-03 GEFITINIB (FILM-COATED) 250 MG Unknown — — 1 — — 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.

🗺️ Where J8565 is utilized

⏳
The geographic utilization map is building for this code — it aggregates millions of CMS Part B claim lines, then caches the result. Refresh in a moment; if it doesn’t appear, this code may have no reportable Part B utilization.

📊 What bills under J8565

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
Gefitinib 5
NDC products by labeler
Teva Pharmaceuticals, Inc. 2
AstraZeneca Pharmaceuticals LP 1
Ingenus Pharmaceuticals, LLC 1
Natco Pharma USA LLC 1

🗃️ 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
Loaded
Payment limit & billing unit
CMS Medicare Part B ASP Pricing File (quarterly)
Not available
NDC ↔ HCPCS crosswalk
CMS ASP NDC-HCPCS crosswalk + DMEPDAC (PDAC)
5 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
No reportable utilization
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.

❓ J8565 billing FAQ

What is HCPCS code J8565?
J8565 is a HCPCS Level II J-code used to bill Gefitinib, oral, 250 mg under Medicare Part B and most medical (not pharmacy) benefits.
Which NDCs bill under J8565?
5 NDCs currently map to J8565 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 J8565 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.