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  4. NDC Product Code: 79952-110 Zynlonta

NDC 79952-110 Zynlonta

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 79952-110?
  4. Zynlonta Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing expired due to lack of listing certification.

Get all the details for National Drug Code (NDC) 79952-110 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
79952-110
Proprietary Name:
Zynlonta
Product Type: [3]
Labeler Name: [5]
Adc Therapeutics America, Inc.
Labeler Code:
79952
Product Label ID:
af54af12-3edf-4301-8bc5-0446bc813c1d
HCPCS Code:
J9359 - Inj lon tesirin-lpyl 0.075mg
FDA Application Number: [6]
BLA761196
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
04-30-2021
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
U
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Product Details

What is NDC 79952-110?

The NDC code 79952-110 is assigned by the FDA to the product Zynlonta which is product labeled by Adc Therapeutics America, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 79952-110-01 1 vial, single-dose in 1 carton / 2 ml in 1 vial, single-dose. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Zynlonta?

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).

Which are Zynlonta UNII Codes?

The UNII codes for the active ingredients in this product are:

  • LONCASTUXIMAB TESIRINE (UNII: 7K5O7P6QIU)
  • LONCASTUXIMAB TESIRINE (UNII: 7K5O7P6QIU) (Active Moiety)

Which are Zynlonta Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Zynlonta?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

* Please review the disclaimer below.

Patient Education

Loncastuximab Tesirine-lpyl Injection


Loncastuximab tesirine-lpyl injection is used to treat a certain type of non-Hodgkin's lymphoma (NHL; a type of cancer that begins in a type of white blood cells that normally fights infection) that did not respond to or has returned after treatment with at least two other cancer treatments. Loncastuximab tesirine-lpyl is in a class of medications called antibody-drug conjugates. It works by killing cancer cells.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".