Zynlonta Injection, Powder, Lyophilized, For Solution
NDC Package 79952-110-01

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

Zynlonta (loncastuximab tesirine) injection is zYNLONTA is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.1)]. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Adc Therapeutics America, Inc., this product is identified by NDC 79952-110 and is authorized under FDA application BLA761196.

Identification & Billing

NDC Package Code
79952-110-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE
Product Code
79952-110
11-Digit Billing Format
79952011001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Zynlonta
Non-Proprietary Name
Loncastuximab Tesirine
Substance Name
Loncastuximab Tesirine
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
LONCASTUXIMAB TESIRINE 10 mg/2mL
Usage Information
ZYNLONTA is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Regulatory & Marketing

Labeler Name
Adc Therapeutics America, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761196
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-30-2021
Listing Expiration
12-31-2027
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.

J9359
Source: ASP
Inj lon tesirin-lpyl 0.075mg
HCPCS Dosage 0.075 MG
Units / Pkg 134

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 79952-110-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 2 ml in 1 vial, single-dose of Zynlonta, a human prescription drug labeled by Adc Therapeutics America, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains loncastuximab tesirine 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 Adc Therapeutics America, Inc. on April 30, 2021. The current certification is valid through December 31, 2027.

How is this Adc Therapeutics America, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 79952011001. 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 (5-3-2)
79952-110-01
11-Digit CMS (5-4-2)
79952-0110-01

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