Eltrombopag Olamine Powder
NDC Package 58159-111-03

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

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.

Eltrombopag Olamine powders is a medication used to treat low platelet levels in people who have a certain blood disorder called chronic immune (idiopathic) thrombocytopenia purpura (ITP) or who have chronic hepatitis C. This formulation utilizes a powder delivery system. Marketed by Nuray Chemicals Private Limited, this product is identified by NDC 58159-111.

Identification & Billing

NDC Package Code
58159-111-03
Package Description
15 kg in 1 DRUM
Product Code
58159-111
11-Digit Billing Format
58159011103

Clinical Specifications

Proprietary Name
Eltrombopag Olamine
Non-Proprietary Name
Eltrombopag Olamine
Substance Name
Eltrombopag Olamine
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)
ELTROMBOPAG OLAMINE 35 kg/35kg
Usage Information
This medication is used to treat low platelet levels in people who have a certain blood disorder called chronic immune (idiopathic) thrombocytopenia purpura (ITP) or who have chronic hepatitis C. It may also be used to treat people with a certain blood disorder (aplastic anemia). Platelets are a type of blood cell needed to form blood clots and prevent bleeding. Eltrombopag decreases your risk of bleeding by increasing the number of platelets. Eltrombopag acts like a certain natural substance (thrombopoietin) that causes the body to produce platelets.

Regulatory & Marketing

Labeler Name
Nuray Chemicals Private Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
10-30-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (58159-111). Click a package code to view its specific billing and regulatory data.

58159-111-01
35 kg in 1 DRUM
58159-111-02
20 kg in 1 DRUM
58159-111-04
10 kg in 1 DRUM
58159-111-05
5 kg in 1 DRUM

* 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 58159-111-03 identifies a specific commercial package of 15 kg in 1 drum of Eltrombopag Olamine (UNFINISHED drug), a bulk ingredient labeled by Nuray Chemicals Private Limited. This powder is formulated for use and contains eltrombopag olamine 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 Nuray Chemicals Private Limited on October 30, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat low platelet levels in people who have a certain blood disorder called chronic immune (idiopathic) thrombocytopenia purpura (ITP) or who have chronic hepatitis C. It may also be used to treat people with a certain blood disorder (aplastic anemia). Platelets are a type of blood cell needed to form blood clots and prevent bleeding. Eltrombopag decreases your risk of bleeding by increasing the number of platelets. Eltrombopag acts like a certain natural substance (thrombopoietin) that causes the body to produce platelets.

How is this Nuray Chemicals Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58159011103. 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)
58159-111-03
11-Digit CMS (5-4-2)
58159-0111-03

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