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  5. NDC Package Code: 50242-125-01 Columvi

NDC Package 50242-125-01 Columvi

Glofitamab Solution, Concentrate 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:
50242-125-01
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / 2.5 mL in 1 VIAL, SINGLE-DOSE
Product Code:
50242-125
Proprietary Name:
Columvi
Non-Proprietary Name:
Glofitamab
Substance Name:
Glofitamab
Usage Information:
COLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.1)]. 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:
50242012501
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2639786 - glofitamab-gxbm 10 MG in 10 ML Injection
  • RxCUI: 2639786 - 10 ML glofitamab-gxbm 1 MG/ML Injection
  • RxCUI: 2639786 - glofitamab-gxbm 10 MG per 10 ML Injection
  • RxCUI: 2639792 - Columvi 10 MG in 10 ML Injection
  • RxCUI: 2639792 - 10 ML glofitamab-gxbm 1 MG/ML Injection [Columvi]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Genentech, Inc.
    Dosage Form:
    Solution, Concentrate - A liquid preparation (i.e., a substance that flows readily in its natural state) that contains a drug dissolved in a suitable solvent or mixture of mutually miscible solvents; the drug has been strengthened by the evaporation of its nonactive parts.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • GLOFITAMAB 2.5 mg/2.5mL
    • Sample Package:
    No
    FDA Application Number:
    BLA761309
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    06-15-2023
    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 50242-125-01?

    The NDC Packaged Code 50242-125-01 is assigned to a package of 1 vial, single-dose in 1 carton / 2.5 ml in 1 vial, single-dose of Columvi, a human prescription drug labeled by Genentech, Inc.. The product's dosage form is solution, concentrate and is administered via intravenous form.

    Is NDC 50242-125 included in the NDC Directory?

    Yes, Columvi with product code 50242-125 is active and included in the NDC Directory. The product was first marketed by Genentech, Inc. on June 15, 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 50242-125-01?

    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 50242-125-01?

    The 11-digit format is 50242012501. 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
    5-3-250242-125-015-4-250242-0125-01