Orserdu Tablet, Film Coated
NDC Package 72187-0102-3

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

Package Information

Orserdu (elacestrant) tablets is oRSERDU is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. This formulation utilizes a tablet, film coated delivery system. Marketed by Stemline Therapeutics, Inc., this product is identified by NDC 72187-0102 and is authorized under FDA application NDA217639.

Identification & Billing

NDC Package Code
72187-0102-3
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
72187-0102
11-Digit Billing Format
72187010203
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Orserdu
Non-Proprietary Name
Elacestrant
Substance Name
Elacestrant
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ELACESTRANT 345 mg/1
Pharmacologic Class
Usage Information
ORSERDU is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

Regulatory & Marketing

Labeler Name
Stemline Therapeutics, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA217639
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-27-2023
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72187-0102-3 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Orserdu, a human prescription drug labeled by Stemline Therapeutics, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This tablet, film coated is formulated for oral use and contains elacestrant 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 Stemline Therapeutics, Inc. on January 27, 2023. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72187010203. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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 (5-4-1)
72187-0102-3
11-Digit CMS (5-4-2)
72187-0102-03

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