Utibron Neohaler
NDC Package 63402-681-06
Package Information
Utibron Neohaler is a medication used to control and prevent symptoms (such as wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). Marketed by Sunovion Pharmaceuticals Inc., this product is identified by NDC 63402-681 and is authorized under FDA application NDA207930.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 63402 - Sunovion Pharmaceuticals Inc.
- 63402-681 - Utibron Neohaler
- 63402-681-06 - 1 BLISTER PACK in 1 CARTON / 6 CAPSULE in 1 BLISTER PACK (63402-681-01) / 1 CAPSULE in 1 CAPSULE
- 63402-681 - Utibron Neohaler
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 (63402-681). Click a package code to view its specific billing and regulatory data.
* 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 63402-681-06 identifies a specific commercial package of 1 blister pack in 1 carton / 6 capsule in 1 blister pack (63402-681-01) / 1 capsule in 1 capsule of Utibron 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 October 29, 2015. The current certification is valid through April 30, 2021.
What are the primary indications for this medication?
This product is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). Controlling symptoms of breathing problems helps you stay active. This inhaler contains 2 medications: indacaterol and glycopyrrolate. Both drugs work by relaxing the muscles around the airways so that they open up and you can breathe more easily. Indacaterol belongs to the class of drugs known as long-acting beta agonists (LABAs). Glycopyrrolate belongs to a class of drugs known as anticholinergics. Both drugs are also known as bronchodilators. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden shortness of breath. If sudden breathing problems occur, use your quick-relief inhaler as prescribed. Indacaterol/glycopyrrolate 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: 63402068106. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
