Mepolizumab Liquid
NDC Package 58437-009-01

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.

Mepolizumab liquids is a medication used along with other medications to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. This formulation utilizes a liquid delivery system. Marketed by Glaxosmithkline Llc, this product is identified by NDC 58437-009.

Identification & Billing

NDC Package Code
58437-009-01
Package Description
8.37 kg in 1 BOTTLE
Product Code
58437-009
11-Digit Billing Format
58437000901

Clinical Specifications

Proprietary Name
Mepolizumab
Non-Proprietary Name
Mepolizumab
Substance Name
Mepolizumab
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Active Ingredient(s)
MEPOLIZUMAB 1 kg/kg
Usage Information
This medication is used along with other medications to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. Controlling symptoms of asthma helps you do your normal activities and decreases time lost from work or school. Mepolizumab works by reducing swelling (inflammation) of the airways in the lungs to make breathing easier. Mepolizumab is also used to treat a certain immune system diseases (eosinophilic granulomatosis with polyangiitis-EGPA, hypereosinophilic syndrome-HES). It helps to control and prevent symptoms (such as wheezing, shortness of breath, runny nose, facial pain, tiredness) caused by these diseases. It works by decreasing the amount of certain white blood cells (eosinophils) which may cause these diseases. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks or breathing problems. If an asthma attack occurs, use your quick-relief inhaler as prescribed.

Regulatory & Marketing

Labeler Name
Glaxosmithkline Llc
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-01-2020
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 58437-009-01 identifies a specific commercial package of 8.37 kg in 1 bottle of Mepolizumab (UNFINISHED drug), a bulk ingredient labeled by Glaxosmithkline Llc. This liquid is formulated for use and contains mepolizumab 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 Glaxosmithkline Llc on January 01, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used along with other medications to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. Controlling symptoms of asthma helps you do your normal activities and decreases time lost from work or school. Mepolizumab works by reducing swelling (inflammation) of the airways in the lungs to make breathing easier. Mepolizumab is also used to treat a certain immune system diseases (eosinophilic granulomatosis with polyangiitis-EGPA, hypereosinophilic syndrome-HES). It helps to control and prevent symptoms (such as wheezing, shortness of breath, runny nose, facial pain, tiredness) caused by these diseases. It works by decreasing the amount of certain white blood cells (eosinophils) which may cause these diseases. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks or breathing problems. If an asthma attack occurs, use your quick-relief inhaler as prescribed.

How is this Glaxosmithkline Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58437000901. 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)
58437-009-01
11-Digit CMS (5-4-2)
58437-0009-01

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