Elrexfio Injection, Solution
NDC Package 63539-252-02

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

Package Information

Elrexfio (elranatamab-bcmm) injection is eLREXFIO 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 formulation utilizes a injection, solution delivery system. Marketed by U.s. Pharmaceuticals, this product is identified by NDC 63539-252 and is authorized under FDA application BLA761345.

Identification & Billing

NDC Package Code
63539-252-02
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 1.1 mL in 1 VIAL, SINGLE-DOSE (63539-252-01)
Product Code
63539-252
11-Digit Billing Format
63539025202
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Elrexfio
Non-Proprietary Name
Elranatamab-bcmm
Substance Name
Elranatamab
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)
ELRANATAMAB 44 mg/1.1mL
Usage Information
ELREXFIO 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 of clinical benefit in a confirmatory trial(s).

Regulatory & Marketing

Labeler Name
U.s. Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
BLA761345
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-15-2023
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
Yes

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63539-252-02 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 1.1 ml in 1 vial, single-dose (63539-252-01) of Elrexfio, a human prescription drug labeled by U.s. Pharmaceuticals. This injection, solution is formulated for subcutaneous use and contains elranatamab 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 U.s. Pharmaceuticals on August 15, 2023. The current certification is valid through December 31, 2027.

How is this U.s. Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63539025202. 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)
63539-252-02
11-Digit CMS (5-4-2)
63539-0252-02

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