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  5. NDC Package Code: 57894-470-01 Talvey

NDC Package 57894-470-01 Talvey

Talquetamab Injection Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
57894-470-01
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE
Product Code:
57894-470
Proprietary Name:
Talvey
Non-Proprietary Name:
Talquetamab
Substance Name:
Talquetamab
Usage Information:
TALVEY is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
11-Digit NDC Billing Format:
57894047001
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2644452 - talquetamab-tgvs 3 MG in 1.5 ML Injection
  • RxCUI: 2644452 - 1.5 ML talquetamab-tgvs 2 MG/ML Injection
  • RxCUI: 2644452 - talquetamab-tgvs 3 MG per 1.5 ML Injection
  • RxCUI: 2644458 - Talvey 3 MG in 1.5 ML Injection
  • RxCUI: 2644458 - 1.5 ML talquetamab-tgvs 2 MG/ML Injection [Talvey]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Janssen Biotech, Inc.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • TALQUETAMAB 40 mg/mL
    • Sample Package:
    No
    FDA Application Number:
    BLA761342
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    08-09-2023
    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.

    Frequently Asked Questions

    What is NDC 57894-470-01?

    The NDC Packaged Code 57894-470-01 is assigned to a package of 1 vial, single-dose in 1 carton / 1 ml in 1 vial, single-dose of Talvey, a human prescription drug labeled by Janssen Biotech, Inc.. The product's dosage form is injection and is administered via subcutaneous form.

    Is NDC 57894-470 included in the NDC Directory?

    Yes, Talvey with product code 57894-470 is active and included in the NDC Directory. The product was first marketed by Janssen Biotech, Inc. on August 09, 2023 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 57894-470-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 57894-470-01?

    The 11-digit format is 57894047001. 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
    5-3-257894-470-015-4-257894-0470-01