Tudorza Pressair
NDC Package 0310-0800-95

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.

Tudorza Pressair is aclidinium is used to control and prevent symptoms (such as wheezing, shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis and emphysema). Marketed by Astrazeneca Pharmaceuticals Lp, this product is identified by NDC 0310-0800 and is authorized under FDA application NDA202450.

Identification & Billing

NDC Package Code
0310-0800-95
Package Description
1 POUCH in 1 CARTON / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER
Product Code
11-Digit Billing Format
00310080095

Clinical Specifications

Proprietary Name
Tudorza Pressair
Dosage Form
-
Usage Information
Aclidinium is used to control and prevent symptoms (such as wheezing, shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis and emphysema). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Aclidinium belongs to a class of drugs known as anticholinergics. Controlling symptoms of breathing problems can decrease time lost from work or school. This medication must be used regularly to be effective. It 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 (such as albuterol, also called salbutamol in some countries) as prescribed.

Regulatory & Marketing

Labeler Name
Astrazeneca Pharmaceuticals Lp
FDA Application #
NDA202450
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-01-2015
End Marketing Date
07-31-2024
Listing Expiration
07-31-2024
Exclude Flag
D
Sample Package
Yes

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 (0310-0800). Click a package code to view its specific billing and regulatory data.

1 POUCH in 1 CARTON / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER
1 POUCH in 1 CARTON / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER

* 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 0310-0800-95 identifies a specific commercial package of 1 pouch in 1 carton / 1 inhaler in 1 pouch / 30 powder, metered in 1 inhaler of Tudorza Pressair, labeled by Astrazeneca Pharmaceuticals Lp. 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 Astrazeneca Pharmaceuticals Lp on July 01, 2015. The current certification is valid through July 31, 2024.

What are the primary indications for this medication?

Aclidinium is used to control and prevent symptoms (such as wheezing, shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis and emphysema). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Aclidinium belongs to a class of drugs known as anticholinergics. Controlling symptoms of breathing problems can decrease time lost from work or school. This medication must be used regularly to be effective. It 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 (such as albuterol, also called salbutamol in some countries) as prescribed.

How is this Astrazeneca Pharmaceuticals Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00310080095. 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)
0310-0800-95
11-Digit CMS (5-4-2)
00310-0800-95

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