DARZALEX J Code: J9145

Drug & Product Overview

HCPCS Descriptor Injection, daratumumab, 10 mg

HCPCS Added Date January 1, 2017

Manufacturer Janssen

Route of Administration Intravenous

Generic Status Single-Source; Branded

Dosage Type Single-Dose

Dosage Form Injection, Solution, Concentrate

About DARZALEX

Darzalex is a medication aligned to the HCPCS J Code: J9145 for billing, pricing, and reimbursement purposes in the United States. It is an Oncology drug administered via the intravenous route and manufactured by Janssen.

According to CMS Drug Use Information: This medication is used to treat a certain type of cancer (multiple myeloma). Daratumumab belongs to a class of drugs known as monoclonal antibodies. It works by slowing or stopping the growth of cancer cells.

Disclaimer: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional.

NDC Code Information

Based on publicly available CMS files. The list of NDCs below is not exhaustive.

NDC Code	Drug	Manufacturer	Billing Units / Pkg	Package Size
57894-0505-05	Darzalex IV	Janssen Biotech, Inc.	10	100 MG / 5 ML
57894-0505-20	Darzalex IV	Janssen Biotech, Inc.	40	100 MG / 5 ML

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DARZALEX Pricing & Reimbursement

J9145 Private Payer Reimbursement

$73.41 / HCPCS unit as of Jan 2026

National median reimbursement across major commercial payers.

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Historical Graphing and Billing Calculator

per HCPCS unit

As of Q3 2026

DARZALEX Claims Performance

Claims from Jan 2026 – Aug 2026

Claim Denial Rate 12.78%

Avg. Days to File 8.9days

Avg. Days to Pay 26.3days

Real-world claims performance from FocalPoint, OnPoint Oncology's reimbursement analytics platform, with claims data accrued at the clearing house level.

Explore J9145 claims analytics on FocalPoint →

DARZALEX CPT Administration Codes

CPT Code	Description
96413	Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug
96415	Chemotherapy administration, intravenous infusion technique; each additional hour (List separately in addition to code for primary procedure)

JW / JZ modifiers apply

CMS has identified Darzalex (J9145) as a HCPCS code with single-dose containers. Therefore, the JW/JZ wastage modifiers could be required for billing purposes. Wastage billing guide →

DARZALEX Medically Unlikely Edits (MUE)

The most billing units of J9145 Medicare will pay for one patient in one day, as published by CMS. 1 unit = 10 mg.

Practitioner Office & Hospital Outpatient

240 units / day

= 2,400 mg per day

MAI 3 · Date of Service Edit: Clinical. Per-day limit based on clinical expectations; excess units are denied but may be appealed with documentation of medical necessity. See all MUE limits →

DARZALEX Clinical Information

Indications and drug classification.

Treated Diseases & Conditions

This list of indications is not exhaustive and may be subject to errors. The information on BuyandBill.com is intended for informational purposes only and should not be used for medical advice.

Multiple myeloma

Drug Class

AntibodiesMonoclonal [CS]CD38-directed Antibody Interactions [MoA]CD38-directed Cytolytic Antibody [EPC]

Frequently Asked Questions

Is there an available Darzalex billing and coding guide?

Billing and coding information for DARZALEX can be found through Janssen. Visit Here →

Are there any available Darzalex patient assistance programs?

DARZALEX patient assistance information can be found through Janssen. Visit Here →

Where can I find Darzalex prescribing information?

DARZALEX prescribing information can be found at the link below: Visit Here →

Where can I find Darzalex side effect information?

Information regarding DARZALEX's side effects can be found at MedlinePlus Visit Here →

Does billing DARZALEX require JZ/JW wastage modifiers?

CMS has identified DARZALEX(J9145) as a HCPCS code with single-dose containers. Therefore, the JW/JZ wastage modifiers could be required for billing purposes. See CMS guidelines on use of the JZ and JW wastage modifiers below.

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