Orilissa Tablet, Film Coated
NDC Package 0074-0039-01

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

Orilissa (elagolix) tablets is a medication used by women to help relieve moderate to severe pain due to a condition called endometriosis. This formulation utilizes a tablet, film coated delivery system. Marketed by Abbvie Inc., this product is identified by NDC 0074-0039 and is authorized under FDA application NDA210450.

Identification & Billing

NDC Package Code
0074-0039-01
Package Description
1 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
0074-0039
11-Digit Billing Format
00074003901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Orilissa
Non-Proprietary Name
Elagolix
Substance Name
Elagolix Sodium
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)
ELAGOLIX SODIUM 200 mg/1
Pharmacologic Class
Usage Information
This medication is used by women to help relieve moderate to severe pain due to a condition called endometriosis. Endometriosis is the growth of tissue that normally lines the inside of the womb (uterus) in a different place, such as on the outside surface of the uterus, on the ovaries, or on other organs. This condition may cause symptoms such as painful/heavy/irregular menstrual periods, pain during or after sex, or infertility. Elagolix works by decreasing your body's production of certain hormones (luteinizing hormone, follicle-stimulating hormone), which leads to lower amounts of female sex hormones (estrogens). These lower levels may help decrease some symptoms of endometriosis.

Regulatory & Marketing

Labeler Name
Abbvie Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA210450
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-23-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0074-0039). Click a package code to view its specific billing and regulatory data.

0074-0039-14
1 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 BLISTER PACK
0074-0039-56
4 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 BLISTER PACK

* 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 0074-0039-01 identifies a specific commercial package of 1 blister pack in 1 carton / 14 tablet, film coated in 1 blister pack of Orilissa, a human prescription drug labeled by Abbvie Inc.. This tablet, film coated is formulated for oral use and contains elagolix sodium 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 Abbvie Inc. on July 23, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used by women to help relieve moderate to severe pain due to a condition called endometriosis. Endometriosis is the growth of tissue that normally lines the inside of the womb (uterus) in a different place, such as on the outside surface of the uterus, on the ovaries, or on other organs. This condition may cause symptoms such as painful/heavy/irregular menstrual periods, pain during or after sex, or infertility. Elagolix works by decreasing your body's production of certain hormones (luteinizing hormone, follicle-stimulating hormone), which leads to lower amounts of female sex hormones (estrogens). These lower levels may help decrease some symptoms of endometriosis.

How is this Abbvie Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00074003901. 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 (4-4-2)
0074-0039-01
11-Digit CMS (5-4-2)
00074-0039-01

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