Tudorza Pressair Powder, Metered
NDC Package 70515-002-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Tudorza Pressair (aclidinium bromide) powders 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). This formulation utilizes a powder, metered delivery system. Marketed by Covis Pharma Us, Inc, this product is identified by NDC 70515-002 and is authorized under FDA application NDA202450.

Identification & Billing

NDC Package Code
70515-002-01
Package Description
1 POUCH in 1 CARTON / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER
Product Code
70515-002
11-Digit Billing Format
70515000201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 1303102 - aclidinium bromide 400 MCG/INHAL Dry Powder Inhaler, 60 ACTUAT
  • RxCUI: 1303102 - 60 ACTUAT aclidinium bromide 0.4 MG/ACTUAT Dry Powder Inhaler
  • RxCUI: 1303102 - 60 ACTUAT aclidinium bromide 400 MCG/ACTUAT Dry Powder Inhaler
  • RxCUI: 1303102 - aclidinium bromide 0.4 MG/ACTUAT Dry Powder Inhaler, 60 ACTUAT
  • RxCUI: 1303107 - Tudorza Pressair 400 MCG/INHAL Dry Powder Inhaler, 60 ACTUAT

Clinical Specifications

Proprietary Name
Tudorza Pressair
Non-Proprietary Name
Aclidinium Bromide
Substance Name
Aclidinium Bromide
Dosage Form
Powder, Metered - An powder dosage form that is situated inside a container that has a mechanism to deliver a specified quantity.
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
ACLIDINIUM BROMIDE 400 ug/1
Pharmacologic Class
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
Covis Pharma Us, Inc
Product Type
Human Prescription Drug
FDA Application #
NDA202450
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-01-2015
Listing Expiration
12-31-2026
Exclude Flag
N
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 (70515-002). Click a package code to view its specific billing and regulatory data.

70515-002-02
1 POUCH in 1 CARTON / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER
70515-002-03
1 POUCH in 1 CARTON / 1 INHALER in 1 POUCH / 30 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 70515-002-01 identifies a specific commercial package of 1 pouch in 1 carton / 1 inhaler in 1 pouch / 60 powder, metered in 1 inhaler of Tudorza Pressair, a human prescription drug labeled by Covis Pharma Us, Inc. This powder, metered is formulated for respiratory (inhalation) use and contains aclidinium bromide 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 Covis Pharma Us, Inc on July 01, 2015. The current certification is valid through December 31, 2026.

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 Covis Pharma Us, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70515000201. 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)
70515-002-01
11-Digit CMS (5-4-2)
70515-0002-01

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