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  5. NDC Package Code: 57894-111-01 Carvykti

NDC Package 57894-111-01 Carvykti

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

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. 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:
57894-111-01
Package Description:
1 INJECTION, SUSPENSION in 1 BAG
Product Code:
57894-111
Proprietary Name:
Carvykti
Non-Proprietary Name:
Ciltacabtagene Autoleucel
Substance Name:
Ciltacabtagene Autoleucel
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.
11-Digit NDC Billing Format:
57894011101
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: 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]
    • Product Type:
    Cellular Therapy
    Labeler Name:
    Janssen Biotech, Inc
    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):
  • CILTACABTAGENE AUTOLEUCEL 100000000 1/1
    • Sample Package:
    No
    FDA Application Number:
    BLA125746
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    02-28-2022
    Listing Expiration Date:
    12-31-2025
    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 57894-111-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    57894011101Q2056Ciltacabtagene car-pos tup to 100 million autologous b-cell maturation antigen (bcma) directed car-positive t cells1111

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    57894-111-021 INJECTION, SUSPENSION in 1 BAG

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 57894-111-01?

    The NDC Packaged Code 57894-111-01 is assigned to a package of 1 injection, suspension in 1 bag of Carvykti, a cellular therapy labeled by Janssen Biotech, Inc. 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 57894-111 included in the NDC Directory?

    Yes, Carvykti with product code 57894-111 is active and included in the NDC Directory. The product was first marketed by Janssen Biotech, Inc on February 28, 2022 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 57894-111-01?

    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 57894-111-01?

    The 11-digit format is 57894011101. 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 5-3-2 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
    5-3-257894-111-015-4-257894-0111-01