Carvykti Injection, Suspension
NDC Package 57894-111-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Carvykti (ciltacabtagene autoleucel) injection is cARVYKTI is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This formulation utilizes a injection, suspension delivery system. Marketed by Janssen Biotech, Inc., this product is identified by NDC 57894-111 and is authorized under FDA application BLA125746.

Identification & Billing

NDC Package Code
57894-111-01
Package Description
1 INJECTION, SUSPENSION in 1 BAG
Product Code
57894-111
11-Digit Billing Format
57894011101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 2594780 - ciltacabtagene autoleucel 100,000,000 CELLS in 70 ML Injection
  • RxCUI: 2594780 - 70 ML ciltacabtagene autoleucel 1430000 CELLS/ML Injection
  • RxCUI: 2594780 - ciltacabtagene autoleucel 100,000,000 CELLS per 70 ML Injection
  • RxCUI: 2594786 - CARVYKTI 100,000,000 CELLS in 70 ML Injection
  • RxCUI: 2594786 - 70 ML ciltacabtagene autoleucel 1430000 CELLS/ML Injection [Carvykti]

Clinical Specifications

Proprietary Name
Carvykti
Non-Proprietary Name
Ciltacabtagene Autoleucel
Substance Name
Ciltacabtagene Autoleucel
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)
CILTACABTAGENE AUTOLEUCEL 100000000 1/1
Usage Information
CARVYKTI is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Regulatory & Marketing

Labeler Name
Janssen Biotech, Inc.
Product Type
Cellular Therapy
FDA Application #
BLA125746
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
02-28-2022
Listing Expiration
12-31-2027
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.

Q2056
Source: ASP
Ciltacabtagene car-pos t
HCPCS Dosage UP TO 100 million autologous b-cell maturation antigen (bcma) directed car-positive 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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (57894-111). Click a package code to view its specific billing and regulatory data.

57894-111-02
1 INJECTION, SUSPENSION in 1 BAG

* 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 57894-111-01 identifies a specific commercial package of 1 injection, suspension in 1 bag of Carvykti, a cellular therapy labeled by Janssen Biotech, Inc.. 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 ciltacabtagene autoleucel 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 Janssen Biotech, Inc. on February 28, 2022. The current certification is valid through December 31, 2027.

How is this Janssen Biotech, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57894011101. 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 (5-3-2)
57894-111-01
11-Digit CMS (5-4-2)
57894-0111-01

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