Epkinly Injection, Solution
NDC Package 82705-002-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Epkinly (epcoritamab-bysp) injection is 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)]. This formulation utilizes a injection, solution delivery system. Marketed by Genmab Us, Inc., this product is identified by NDC 82705-002 and is authorized under FDA application BLA761324.

Identification & Billing

NDC Package Code
82705-002-01
Package Description
1 VIAL, GLASS in 1 CARTON / .8 mL in 1 VIAL, GLASS
Product Code
82705-002
11-Digit Billing Format
82705000201
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Epkinly
Non-Proprietary Name
Epcoritamab-bysp
Substance Name
Epcoritamab
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
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
EPCORITAMAB 4 mg/.8mL
Pharmacologic Class
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).

Regulatory & Marketing

Labeler Name
Genmab Us, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761324
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-19-2023
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J9321
Source: ASP
Inj epcoritamab-bysp 0.16 mg
HCPCS Dosage 0.16 MG
Units / Pkg 25

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 82705-002-01 identifies a specific commercial 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.. This injection, solution is formulated for subcutaneous use and contains epcoritamab as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Genmab Us, Inc. on May 19, 2023. The current certification is valid through December 31, 2027.

How is this Genmab Us, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82705000201. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
82705-002-01
11-Digit CMS (5-4-2)
82705-0002-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.