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  5. NDC Package Code: 0310-0800-95 Tudorza Pressair

NDC Package 0310-0800-95 Tudorza Pressair

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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:
0310-0800
Proprietary Name:
Tudorza Pressair
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.
11-Digit NDC Billing Format:
00310080095
Labeler Name:
Astrazeneca Pharmaceuticals Lp
Sample Package:
Yes
FDA Application Number:
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 Date:
07-31-2024
Exclude Flag:
D
Code Structure:

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
0310-0800-391 POUCH in 1 CARTON / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER
0310-0800-601 POUCH in 1 CARTON / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0310-0800-95?

The NDC Packaged Code 0310-0800-95 is assigned to a 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. The product's dosage form is and is administered via form.

Is NDC 0310-0800 included in the NDC Directory?

No, Tudorza Pressair with product code 0310-0800 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Astrazeneca Pharmaceuticals Lp on July 01, 2015 and its listing in the NDC Directory is set to expire on July 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0310-0800-95?

The 11-digit format is 00310080095. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20310-0800-955-4-200310-0800-95