1. Home
  2. Labeler Index
  3. Genmab Us, Inc.
  4. 82705-010
  5. NDC Package Code: 82705-010-01 Epkinly

NDC Package 82705-010-01 Epkinly

Epcoritamab-bysp Injection, Solution 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:
82705-010-01
Package Description:
1 VIAL, GLASS in 1 CARTON / .8 mL in 1 VIAL, GLASS
Product Code:
82705-010
Proprietary Name:
Epkinly
Non-Proprietary Name:
Epcoritamab-bysp
Substance Name:
Epcoritamab
Usage Information:
EPKINLY is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell 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)]. 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:
82705001001
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2637399 - epcoritamab-bysp 48 MG in 0.8 ML Injection
  • RxCUI: 2637399 - 0.8 ML epcoritamab-bysp 60 MG/ML Injection
  • RxCUI: 2637399 - epcoritamab-bysp 48 MG per 0.8 ML Injection
  • RxCUI: 2637405 - epkinly 48 MG in 0.8 ML Injection
  • RxCUI: 2637405 - 0.8 ML epcoritamab-bysp 60 MG/ML Injection [Epkinly]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Genmab Us, Inc.
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • EPCORITAMAB 48 mg/.8mL
    • Sample Package:
    No
    FDA Application Number:
    BLA761324
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    05-19-2023
    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 82705-010-01?

    The NDC Packaged Code 82705-010-01 is assigned to a package of 1 vial, glass in 1 carton / .8 ml in 1 vial, glass of Epkinly, a human prescription drug labeled by Genmab Us, Inc.. The product's dosage form is injection, solution and is administered via subcutaneous form.

    Is NDC 82705-010 included in the NDC Directory?

    Yes, Epkinly with product code 82705-010 is active and included in the NDC Directory. The product was first marketed by Genmab Us, Inc. on May 19, 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 82705-010-01?

    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 82705-010-01?

    The 11-digit format is 82705001001. 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
    5-3-282705-010-015-4-282705-0010-01