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  5. NDC Package Code: 0078-0846-19 Kymriah

NDC Package 0078-0846-19 Kymriah

Tisagenlecleucel Injection, Suspension Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. 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:
0078-0846-19
Package Description:
1 INJECTION, SUSPENSION in 1 BAG
Product Code:
0078-0846
Proprietary Name:
Kymriah
Non-Proprietary Name:
Tisagenlecleucel
Substance Name:
Tisagenlecleucel
Usage Information:
KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.
11-Digit NDC Billing Format:
00078084619
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: 1986442 - tisagenlecleucel 250000000 CELLS Injection
  • RxCUI: 1986442 - tisagenlecleucel-T 250,000,000 CELLS Injection
  • RxCUI: 1986447 - KYMRIAH 250,000,000 CELLS Injection
  • RxCUI: 1986447 - tisagenlecleucel 250000000 CELLS Injection [Kymriah]
  • RxCUI: 1986447 - Kymriah 250000000 CELLS Injection
    • Product Type:
    Cellular Therapy
    Labeler Name:
    Novartis Pharmaceuticals Corporation
    Dosage Form:
    Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • TISAGENLECLEUCEL 2000000 1/1
    • Pharmacologic Class(es):
  • CD19 Receptor Interactions - [MoA] (Mechanism of Action)
  • CD19-directed Chimeric Antigen Receptor - [EPC] (Established Pharmacologic Class)
  • CD19-specific Chimeric Antigen Receptor - [CS]
  • Genetically-modified Autologous T Cells - [EPC] (Established Pharmacologic Class)
  • Increased T Lymphocyte Activation - [PE] (Physiologic Effect)
  • T Lymphocytes, Cultured, Autologous, Genetically-modified - [EXT]
    • Sample Package:
    No
    FDA Application Number:
    BLA125646
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    08-30-2017
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 0078-0846-19 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00078084619Q2042Tisagenlecleucel car-pos tup to 600 million CAR-positive viable T cells1111

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0078-0846-19?

    The NDC Packaged Code 0078-0846-19 is assigned to a package of 1 injection, suspension in 1 bag of Kymriah, a cellular therapy labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is injection, suspension 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 0078-0846 included in the NDC Directory?

    Yes, Kymriah with product code 0078-0846 is active and included in the NDC Directory. The product was first marketed by Novartis Pharmaceuticals Corporation on August 30, 2017 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 0078-0846-19?

    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 0078-0846-19?

    The 11-digit format is 00078084619. 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 4-4-2 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
    4-4-20078-0846-195-4-200078-0846-19