Elahere Injection, Solution
NDC Package 72903-853-01

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

Elahere (mirvetuximab soravtansine) injection is eLAHERE™ is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. This formulation utilizes a injection, solution delivery system. Marketed by Immunogen, Inc., this product is identified by NDC 72903-853 and is authorized under FDA application BLA761310.

Identification & Billing

NDC Package Code
72903-853-01
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-USE
Product Code
72903-853
11-Digit Billing Format
72903085301
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Elahere
Non-Proprietary Name
Mirvetuximab Soravtansine
Substance Name
Mirvetuximab Soravtansine
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
MIRVETUXIMAB SORAVTANSINE 5 mg/mL
Usage Information
ELAHERE™ is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test [see Dosage and Administration (2.1)].This indication is approved under accelerated approval based on tumor 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.

Regulatory & Marketing

Labeler Name
Immunogen, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761310
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-14-2022
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.

J9063
Source: ASP
Inj, elahere, 1 mg
HCPCS Dosage 1 MG
Units / Pkg 100

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 72903-853-01 identifies a specific commercial package of 1 vial, single-use in 1 carton / 20 ml in 1 vial, single-use of Elahere, a human prescription drug labeled by Immunogen, Inc.. This injection, solution is formulated for intravenous use and contains mirvetuximab soravtansine 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 Immunogen, Inc. on November 14, 2022. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72903085301. 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)
72903-853-01
11-Digit CMS (5-4-2)
72903-0853-01

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