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NDC 73153-900 Breyanzi

Lisocabtagene Maraleucel Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 73153-900?
  4. Breyanzi Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

NDC Product Code:
73153-900
Proprietary Name:
Breyanzi
Non-Proprietary Name: [1]
Lisocabtagene Maraleucel
NDC Directory Status:
Cellular Therapy
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Juno Therapeutics, Inc.
Labeler Code:
73153
Product Label ID:
594bb413-af3b-4b97-afb3-bfe2b174f2ed
FDA Application Number: [6]
BLA125714
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
02-05-2021
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Packages

NDC Code 73153-900-01

Package Description: 1 KIT in 1 CARTON * 5 mL in 1 VIAL, SINGLE-DOSE (73153-902-04) * 5 mL in 1 VIAL, SINGLE-DOSE (73153-901-08)

Product Details

What is NDC 73153-900?

The NDC code 73153-900 is assigned by the FDA to the product Breyanzi which is a cellular therapy product labeled by Juno Therapeutics, Inc.. The generic name of Breyanzi is lisocabtagene maraleucel. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 73153-900-01 1 kit in 1 carton * 5 ml in 1 vial, single-dose (73153-902-04) * 5 ml in 1 vial, single-dose (73153-901-08). 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 Breyanzi?

BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy 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 (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.

Which are Breyanzi UNII Codes?

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

  • LISOCABTAGENE MARALEUCEL (UNII: 7K2YOJ14X0)
  • LISOCABTAGENE MARALEUCEL (UNII: 7K2YOJ14X0) (Active Moiety)

Which are Breyanzi 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 Breyanzi?

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:
  • RxCUI: 2479140 - lisocabtagene maraleucel 70,000,000 CELLS/mL in 4.6 mL Injection
  • RxCUI: 2479140 - 4.6 ML lisocabtagene maraleucel 70000000 CELLS/ML Injection
  • RxCUI: 2479140 - lisocabtagene maraleucel 70,000,000 CELLS/ML per 4.6 ML Injection
  • RxCUI: 2479145 - Breyanzi 70,000,000 CELLS/mL in 4.6 mL Injection
  • RxCUI: 2479145 - 4.6 ML lisocabtagene maraleucel 70000000 CELLS/ML Injection [Breyanzi]

* Please review the disclaimer below.

Patient Education

Lisocabtagene Maraleucel Injection


Lisocabtagene maraleucel is used to treat certain types of large B-cell lymphoma (a type of cancer that begins in the white blood cells) in adults whose cancer has returned or is unresponsive to other treatments. Lisocabtagene maraleucel is in a class of medications called autologous cellular immunotherapy, a type of medication prepared using cells from the patient's own blood. It works by causing the body's immune system (a group of cells, tissues, and organs that protects the body from attack by bacteria, viruses, cancer cells, and other substances that cause disease) to fight the cancer cells.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".