Elagolix Sodium Powder
NDC Package 73435-021-11

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Elagolix Sodium powders is a medication used by women to help relieve moderate to severe pain due to a condition called endometriosis. This formulation utilizes a powder delivery system. Marketed by Biophore India Pharmaceuticals Pvt. Ltd, this product is identified by NDC 73435-021.

Identification & Billing

NDC Package Code
73435-021-11
Package Description
20 kg in 1 DRUM
Product Code
73435-021
11-Digit Billing Format
73435002111

Clinical Specifications

Proprietary Name
Elagolix Sodium
Non-Proprietary Name
Elagolix Sodium
Substance Name
Elagolix Sodium
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
ELAGOLIX SODIUM 20 kg/20kg
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
Biophore India Pharmaceuticals Pvt. Ltd
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
12-08-2021
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 73435-021-11 identifies a specific commercial package of 20 kg in 1 drum of Elagolix Sodium (UNFINISHED drug), a bulk ingredient labeled by Biophore India Pharmaceuticals Pvt. Ltd. This powder is formulated for 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 Biophore India Pharmaceuticals Pvt. Ltd on December 08, 2021. 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 Biophore India Pharmaceuticals Pvt. Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73435002111. 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)
73435-021-11
11-Digit CMS (5-4-2)
73435-0021-11

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