Indacaterol Maleate Powder
NDC Package 64567-0024-0

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.

Indacaterol Maleate powders is indacaterol is used to treat trouble breathing and wheezing due to a certain ongoing lung disease (chronic obstructive pulmonary disease-COPD, including chronic bronchitis and/or emphysema). This formulation utilizes a powder delivery system. Marketed by Inke Sa, this product is identified by NDC 64567-0024.

Identification & Billing

NDC Package Code
64567-0024-0
Package Description
5 kg in 1 DRUM
Product Code
64567-0024
11-Digit Billing Format
64567002400

Clinical Specifications

Proprietary Name
Indacaterol Maleate
Non-Proprietary Name
Indacaterol Maleate
Substance Name
Indacaterol
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)
INDACATEROL 1 kg/kg
Usage Information
Indacaterol is used to treat trouble breathing and wheezing due to a certain ongoing lung disease (chronic obstructive pulmonary disease-COPD, including chronic bronchitis and/or emphysema). It is used if your breathing problems are not controlled with other medication (such as a quick-relief inhaler). Indacaterol belongs to the class of drugs known as long-acting beta agonists (LABAs). Indacaterol is also known as a bronchodilator. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. This medication should not be used for severe/sudden breathing problems. Other medications, such as a quick-relief inhaler should be used instead of indacaterol for sudden breathing problems. This medication is not a substitute for corticosteroids (such as beclomethasone, fluticasone, prednisone). Indacaterol is not approved to treat asthma. People with asthma using long-acting inhaled beta agonists (such as indacaterol) without also using an inhaled corticosteroid may have an increased risk of serious (sometimes fatal) breathing problems.

Regulatory & Marketing

Labeler Name
Inke Sa
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-20-2021
Listing Expiration
12-31-2027
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 64567-0024-0 identifies a specific commercial package of 5 kg in 1 drum of Indacaterol Maleate (UNFINISHED drug), a bulk ingredient labeled by Inke Sa. This powder is formulated for use and contains indacaterol 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 Inke Sa on January 20, 2021. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Indacaterol is used to treat trouble breathing and wheezing due to a certain ongoing lung disease (chronic obstructive pulmonary disease-COPD, including chronic bronchitis and/or emphysema). It is used if your breathing problems are not controlled with other medication (such as a quick-relief inhaler). Indacaterol belongs to the class of drugs known as long-acting beta agonists (LABAs). Indacaterol is also known as a bronchodilator. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. This medication should not be used for severe/sudden breathing problems. Other medications, such as a quick-relief inhaler should be used instead of indacaterol for sudden breathing problems. This medication is not a substitute for corticosteroids (such as beclomethasone, fluticasone, prednisone). Indacaterol is not approved to treat asthma. People with asthma using long-acting inhaled beta agonists (such as indacaterol) without also using an inhaled corticosteroid may have an increased risk of serious (sometimes fatal) breathing problems.

How is this Inke Sa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64567002400. 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 (5-4-1)
64567-0024-0
11-Digit CMS (5-4-2)
64567-0024-00

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