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  5. NDC Package Code: 57894-501-01 Rybrevant

NDC Package 57894-501-01 Rybrevant

Amivantamab Injection Intravenous - 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:
57894-501-01
Package Description:
1 VIAL, SINGLE-USE in 1 CARTON / 1 INJECTION in 1 VIAL, SINGLE-USE (57894-501-00)
Product Code:
57894-501
Proprietary Name:
Rybrevant
Non-Proprietary Name:
Amivantamab
Substance Name:
Amivantamab
Usage Information:
RYBREVANT is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1)], whose disease has progressed on or after platinum-based chemotherapy.This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
11-Digit NDC Billing Format:
57894050101
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2549734 - amivantamab-vmjw 350 MG in 7 ML Injection
  • RxCUI: 2549734 - 7 ML amivantamab-vmjw 50 MG/ML Injection
  • RxCUI: 2549734 - amivantamab-vmjw 350 MG per 7 ML Injection
  • RxCUI: 2549734 - amivantamab-vmjw 50 MG/ML per 7 ML Injection
  • RxCUI: 2549739 - Rybrevant 350 MG in 7 ML Injection
    • 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):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • AMIVANTAMAB 350 mg/1
    • Sample Package:
    No
    FDA Application Number:
    BLA761210
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    05-21-2021
    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.

    Frequently Asked Questions

    What is NDC 57894-501-01?

    The NDC Packaged Code 57894-501-01 is assigned to a package of 1 vial, single-use in 1 carton / 1 injection in 1 vial, single-use (57894-501-00) of Rybrevant, a human prescription drug labeled by Janssen Biotech, Inc.. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 57894-501 included in the NDC Directory?

    Yes, Rybrevant with product code 57894-501 is active and included in the NDC Directory. The product was first marketed by Janssen Biotech, Inc. on May 21, 2021 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 57894-501-01?

    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 57894-501-01?

    The 11-digit format is 57894050101. 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
    5-3-257894-501-015-4-257894-0501-01