Seebri Neohaler
NDC Package 63402-815-06

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.

Seebri Neohaler is glycopyrrolate is a long term medication used to treat ongoing lung disease such as chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Marketed by Sunovion Pharmacueticals Inc., this product is identified by NDC 63402-815 and is authorized under FDA application NDA207923.

Identification & Billing

NDC Package Code
63402-815-06
Package Description
1 BLISTER PACK in 1 CARTON / 6 CAPSULE in 1 BLISTER PACK (63402-815-01) / 1 CAPSULE in 1 CAPSULE
Product Code
11-Digit Billing Format
63402081506
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Seebri Neohaler
Dosage Form
-
Usage Information
Glycopyrrolate is a long term medication used to treat ongoing lung disease such as chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It must be used regularly to reduce and prevent symptoms such as shortness of breath and wheezing. This may lead to a decrease in time lost from work due to COPD. This medication belongs to a class of drugs known as anticholinergics. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Glycopyrrolate does not work right away and should not be used to relieve sudden breathing problems. If wheezing or sudden shortness of breath occurs, use your quick-relief inhaler as prescribed.

Regulatory & Marketing

Labeler Name
Sunovion Pharmacueticals Inc.
FDA Application #
NDA207923
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-29-2017
End Marketing Date
10-31-2021
Listing Expiration
10-31-2021
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 (63402-815). Click a package code to view its specific billing and regulatory data.

2 BLISTER PACK in 1 CARTON / 6 CAPSULE in 1 BLISTER PACK (63402-815-02) / 1 CAPSULE in 1 CAPSULE
10 BLISTER PACK in 1 CARTON / 6 CAPSULE in 1 BLISTER PACK (63402-815-01) / 1 CAPSULE in 1 CAPSULE

* 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 63402-815-06 identifies a specific commercial package of 1 blister pack in 1 carton / 6 capsule in 1 blister pack (63402-815-01) / 1 capsule in 1 capsule of Seebri Neohaler, labeled by Sunovion Pharmacueticals Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Pharmacueticals Inc. on October 29, 2017. The current certification is valid through October 31, 2021.

What are the primary indications for this medication?

Glycopyrrolate is a long term medication used to treat ongoing lung disease such as chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It must be used regularly to reduce and prevent symptoms such as shortness of breath and wheezing. This may lead to a decrease in time lost from work due to COPD. This medication belongs to a class of drugs known as anticholinergics. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Glycopyrrolate does not work right away and should not be used to relieve sudden breathing problems. If wheezing or sudden shortness of breath occurs, use your quick-relief inhaler as prescribed.

How is this Sunovion Pharmacueticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63402081506. 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 (5-3-2)
63402-815-06
11-Digit CMS (5-4-2)
63402-0815-06

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