Orgovyx Tablet, Film Coated
NDC Package 72974-120-97

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

Package Information

Orgovyx (relugolix) tablets is oRGOVYX is indicated for the treatment of adult patients with advanced prostate cancer. This formulation utilizes a tablet, film coated delivery system. Marketed by Sumitomo Pharma America, Inc., this product is identified by NDC 72974-120 and is authorized under FDA application NDA214621.

Identification & Billing

NDC Package Code
72974-120-97
Package Description
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
72974-120
11-Digit Billing Format
72974012097
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Orgovyx
Non-Proprietary Name
Relugolix
Substance Name
Relugolix
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)
RELUGOLIX 120 mg/1
Pharmacologic Class
Usage Information
ORGOVYX is indicated for the treatment of adult patients with advanced prostate cancer.

Regulatory & Marketing

Labeler Name
Sumitomo Pharma America, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA214621
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-18-2020
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (72974-120). Click a package code to view its specific billing and regulatory data.

72974-120-01
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
72974-120-95
16 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

* 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 72974-120-97 identifies a specific commercial package of 30 tablet, film coated in 1 bottle, plastic of Orgovyx, a human prescription drug labeled by Sumitomo Pharma America, Inc.. This tablet, film coated is formulated for oral use and contains relugolix 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 Sumitomo Pharma America, Inc. on December 18, 2020. The current certification is valid through December 31, 2026.

How is this Sumitomo Pharma America, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72974012097. 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)
72974-120-97
11-Digit CMS (5-4-2)
72974-0120-97

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