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  5. NDC Package Code: 0310-0800-60 Tudorza Pressair

NDC Package 0310-0800-60 Tudorza Pressair

Aclidinium Bromide Powder, Metered Respiratory (inhalation) - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

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

Package Information

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:
0310-0800-60
Package Description:
1 POUCH in 1 CARTON / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER
Product Code:
0310-0800
Proprietary Name:
Tudorza Pressair
Non-Proprietary Name:
Aclidinium Bromide
Substance Name:
Aclidinium Bromide
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:
00310080060
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Astrazeneca Pharmaceuticals Lp
    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(s):
  • 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(es):
  • Anticholinergic - [EPC] (Established Pharmacologic Class)
  • Cholinergic Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    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
    Exclude Flag:
    N
    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
    0310-0800-951 POUCH in 1 CARTON / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0310-0800-60?

    The NDC Packaged Code 0310-0800-60 is assigned to a 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 Astrazeneca Pharmaceuticals Lp. The product's dosage form is powder, metered and is administered via respiratory (inhalation) form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 0310-0800 included in the NDC Directory?

    Yes, Tudorza Pressair with product code 0310-0800 is active and included in the NDC Directory. The product was first marketed by Astrazeneca Pharmaceuticals Lp on July 01, 2015.

    What is the NDC billing unit for package 0310-0800-60?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 0310-0800-60?

    The 11-digit format is 00310080060. 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
    4-4-20310-0800-605-4-200310-0800-60