Nucala Injection, Powder, For Solution
NDC Package 0173-0881-61

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

Nucala (mepolizumab) injection 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 injection, powder, for solution delivery system. Marketed by Glaxosmithkline Llc, this product is identified by NDC 0173-0881 and is authorized under FDA application BLA125526.

Identification & Billing

NDC Package Code
0173-0881-61
Package Description
1 VIAL in 1 CARTON / 1 mL in 1 VIAL
Product Code
0173-0881
11-Digit Billing Format
00173088161
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nucala
Non-Proprietary Name
Mepolizumab
Substance Name
Mepolizumab
Dosage Form
Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
MEPOLIZUMAB 100 mg/mL
Pharmacologic Class
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
Human Prescription Drug
FDA Application #
BLA125526
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-04-2015
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 (0173-0881). Click a package code to view its specific billing and regulatory data.

0173-0881-01
1 VIAL in 1 CARTON / 1 mL in 1 VIAL

* 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 0173-0881-61 identifies a specific commercial package of 1 vial in 1 carton / 1 ml in 1 vial of Nucala, a human prescription drug labeled by Glaxosmithkline Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, for solution is formulated for subcutaneous 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 November 04, 2015. 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: 00173088161. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
0173-0881-61
11-Digit CMS (5-4-2)
00173-0881-61

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