Arcapta Neohaler
NDC Package 63402-675-06

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Arcapta Neohaler 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). Marketed by Sunovion Pharmaceuticals Inc., this product is identified by NDC 63402-675 and is authorized under FDA application NDA022383.

Identification & Billing

NDC Package Code
63402-675-06
Package Description
1 BLISTER PACK in 1 CARTON / 6 CAPSULE in 1 BLISTER PACK (63402-675-02)
Product Code
11-Digit Billing Format
63402067506

Clinical Specifications

Proprietary Name
Arcapta Neohaler
Dosage Form
-
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
Sunovion Pharmaceuticals Inc.
FDA Application #
NDA022383
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-01-2011
End Marketing Date
01-31-2021
Listing Expiration
01-31-2021
Exclude Flag
D
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 (63402-675). Click a package code to view its specific billing and regulatory data.

5 BLISTER PACK in 1 CARTON / 6 CAPSULE in 1 BLISTER PACK (63402-675-01)

* 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 63402-675-06 identifies a specific commercial package of 1 blister pack in 1 carton / 6 capsule in 1 blister pack (63402-675-02) of Arcapta Neohaler, labeled by Sunovion Pharmaceuticals Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Sunovion Pharmaceuticals Inc. on July 01, 2011. The current certification is valid through January 31, 2021.

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 Sunovion Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63402067506. 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)
63402-675-06
11-Digit CMS (5-4-2)
63402-0675-06

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