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  5. NDC Package Code: 79952-110-01 Zynlonta

NDC Package 79952-110-01 Zynlonta

Loncastuximab Tesirine Injection, Powder, Lyophilized, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Zynlonta
Non-Proprietary Name:
Loncastuximab Tesirine
Substance Name:
Loncastuximab Tesirine
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).
11-Digit NDC Billing Format:
79952011001
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2540969 - loncastuximab tesirine-lpyl 10 MG Injection
  • RxCUI: 2540974 - Zynlonta 10 MG Injection
  • RxCUI: 2540974 - loncastuximab tesirine-lpyl 10 MG Injection [Zynlonta]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Adc Therapeutics America, Inc.
    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(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • LONCASTUXIMAB TESIRINE 10 mg/2mL
    • Sample Package:
    No
    FDA Application Number:
    BLA761196
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    04-30-2021
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 79952-110-01?

    The NDC Packaged Code 79952-110-01 is assigned to a 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.. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 79952-110 included in the NDC Directory?

    Yes, Zynlonta with product code 79952-110 is active and included in the NDC Directory. The product was first marketed by Adc Therapeutics America, Inc. on April 30, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 79952-110-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 79952-110-01?

    The 11-digit format is 79952011001. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-279952-110-015-4-279952-0110-01