NDC Package 72903-853-01 Elahere

Mirvetuximab Soravtansine Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

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:
72903-853-01
Package Description:
1 VIAL, SINGLE-USE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-USE
Product Code:
Proprietary Name:
Elahere
Non-Proprietary Name:
Mirvetuximab Soravtansine
Substance Name:
Mirvetuximab Soravtansine
Usage Information:
ELAHERE™ is indicated for the treatment of adult patients with folate receptor-alpha (FRĪ±) 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.
11-Digit NDC Billing Format:
72903085301
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2621553 - mirvetuximab soravtansine-gynx 100 MG in 20 ML Injection
  • RxCUI: 2621553 - 20 ML mirvetuximab soravtansine-gynx 5 MG/ML Injection
  • RxCUI: 2621553 - mirvetuximab soravtansine-gynx 100 MG per 20 ML Injection
  • RxCUI: 2621553 - mirvetuximab soravtansine-gynx 5 MG/ML per 20 ML Injection
  • RxCUI: 2621559 - ELAHERE 100 MG in 20 ML Injection
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Immunogen, 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):
  • Intravenous - Administration within or into a vein or veins.
  • Sample Package:
    No
    FDA Application Number:
    BLA761310
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    11-14-2022
    Listing Expiration Date:
    12-31-2025
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 72903-853-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    72903085301J9063Inj, elahere, 1 mg1 MG201100100

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 72903-853-01?

    The NDC Packaged Code 72903-853-01 is assigned to a 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.. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 72903-853 included in the NDC Directory?

    Yes, Elahere with product code 72903-853 is active and included in the NDC Directory. The product was first marketed by Immunogen, Inc. on November 14, 2022 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 72903-853-01?

    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 72903-853-01?

    The 11-digit format is 72903085301. 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
    5-3-272903-853-015-4-272903-0853-01