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  5. NDC Package Code: 0310-0900-60 Duaklir Pressair

NDC Package 0310-0900-60 Duaklir Pressair

Aclidinium Bromide And Formoterol Fumarate 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:
0310-0900-60
Package Description:
1 POUCH in 1 CARTON / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER
Product Code:
0310-0900
Proprietary Name:
Duaklir Pressair
Non-Proprietary Name:
Aclidinium Bromide And Formoterol Fumarate
Substance Name:
Aclidinium Bromide; Formoterol Fumarate
Usage Information:
This product is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). Controlling symptoms of breathing problems helps you stay active. This inhaler contains 2 medications: aclidinium and formoterol. Both drugs work 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, and formoterol belongs to a class of drugs known as long-acting beta agonists (LABAs). Both drugs are also known as bronchodilators. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden shortness of breath. If sudden breathing problems occur, use your quick-relief inhaler as prescribed. This medication is not approved to treat asthma.
11-Digit NDC Billing Format:
00310090060
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: 2205094 - aclidinium bromide 400 MCG/ACTUAT / formoterol fumarate 12 MCG/ACTUAT Dry Powder Inhaler, 60 Actuations
  • RxCUI: 2205094 - 60 ACTUAT aclidinium bromide 0.4 MG/ACTUAT / formoterol fumarate 0.012 MG/ACTUAT Dry Powder Inhaler
  • RxCUI: 2205099 - Duaklir Pressair 400/12 MCG/INHAL Dry Powder Inhaler, 60 Actuations
  • RxCUI: 2205099 - 60 ACTUAT aclidinium bromide 0.4 MG/ACTUAT / formoterol fumarate 0.012 MG/ACTUAT Dry Powder Inhaler [Duaklir]
  • RxCUI: 2205099 - Duaklir Pressair 400/12 ( aclidinium bromide 400 MCG/ formoterol fumarate 12 MCG ) per ACTUAT Dry Powder Inhaler, 60 Actuations
    • 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
  • FORMOTEROL FUMARATE 12 ug/1
    • Pharmacologic Class(es):
  • Adrenergic beta2-Agonists - [MoA] (Mechanism of Action)
  • Anticholinergic - [EPC] (Established Pharmacologic Class)
  • Cholinergic Antagonists - [MoA] (Mechanism of Action)
  • beta2-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA210595
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    08-17-2022
    End Marketing Date:
    04-30-2025
    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
    0310-0900-301 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 0310-0900-60?

    The NDC Packaged Code 0310-0900-60 is assigned to a package of 1 pouch in 1 carton / 1 inhaler in 1 pouch / 60 powder, metered in 1 inhaler of Duaklir 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 0310-0900 included in the NDC Directory?

    Yes, Duaklir Pressair with product code 0310-0900 is active and included in the NDC Directory. The product was first marketed by Astrazeneca Pharmaceuticals Lp on August 17, 2022.

    What is the NDC billing unit for package 0310-0900-60?

    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 0310-0900-60?

    The 11-digit format is 00310090060. 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
    4-4-20310-0900-605-4-200310-0900-60