Kymriah Injection, Suspension
NDC Package 0078-0846-19

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

Kymriah (tisagenlecleucel) injection is 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. This formulation utilizes a injection, suspension delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0846 and is authorized under FDA application BLA125646.

Identification & Billing

NDC Package Code
0078-0846-19
Package Description
1 INJECTION, SUSPENSION in 1 BAG
Product Code
0078-0846
11-Digit Billing Format
00078084619
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Kymriah
Non-Proprietary Name
Tisagenlecleucel
Substance Name
Tisagenlecleucel
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
TISAGENLECLEUCEL 2000000 1/1
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
Product Type
Cellular Therapy
FDA Application #
BLA125646
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-30-2017
Listing Expiration
12-31-2026
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.

Q2042
Source: ASP
Tisagenlecleucel car-pos t
HCPCS Dosage UP TO 600 million CAR-positive viable T cells
Units / Pkg 1

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 0078-0846-19 identifies a specific commercial package of 1 injection, suspension in 1 bag of Kymriah, a cellular therapy labeled by Novartis Pharmaceuticals Corporation. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, suspension is formulated for intravenous use and contains tisagenlecleucel 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 Novartis Pharmaceuticals Corporation on August 30, 2017. The current certification is valid through December 31, 2026.

How is this Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078084619. 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 (4-4-2)
0078-0846-19
11-Digit CMS (5-4-2)
00078-0846-19

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