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  5. NDC Package Code: 59310-515-08 Armonair Digihaler

NDC Package 59310-515-08 Armonair Digihaler

Fluticasone Propionate Powder, Metered Respiratory (inhalation) - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
59310-515-08
Package Description:
1 POUCH in 1 CARTON / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER
Product Code:
59310-515
Proprietary Name:
Armonair Digihaler
Non-Proprietary Name:
Fluticasone Propionate
Substance Name:
Fluticasone Propionate
Usage Information:
Fluticasone is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. Controlling symptoms of asthma helps you maintain your normal activities and decreases time lost from work or school. Fluticasone belongs to a class of drugs known as corticosteroids. It works by reducing swelling (inflammation) of the airways in the lungs to make breathing easier. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.
11-Digit NDC Billing Format:
59310051508
NDC to RxNorm Crosswalk:
  • RxCUI: 2395835 - fluticasone propionate 113 MCG/INHAL Dry Powder Inhaler with sensor, 60 Actuations
  • RxCUI: 2395835 - Sensor 60 ACTUAT fluticasone propionate 0.113 MG/ACTUAT Dry Powder Inhaler
  • RxCUI: 2395836 - ArmonAir digihaler 113 MCG/INHAL Dry Powder Inhaler, 60 Actuations
  • RxCUI: 2395836 - Sensor 60 ACTUAT fluticasone propionate 0.113 MG/ACTUAT Dry Powder Inhaler [Armonair]
  • RxCUI: 2395836 - Sensor 60 ACTUAT Armonair 0.113 MG/ACTUAT Dry Powder Inhaler
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Teva Respiratory, Llc
    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):
  • FLUTICASONE PROPIONATE 113 ug/1
    • Pharmacologic Class(es):
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    Yes
    FDA Application Number:
    NDA208798
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    09-15-2020
    Listing Expiration Date:
    12-31-2024
    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.

    Frequently Asked Questions

    What is NDC 59310-515-08?

    The NDC Packaged Code 59310-515-08 is assigned to a package of 1 pouch in 1 carton / 1 inhaler in 1 pouch / 60 powder, metered in 1 inhaler of Armonair Digihaler, a human prescription drug labeled by Teva Respiratory, Llc. The product's dosage form is powder, metered and is administered via respiratory (inhalation) form.

    Is NDC 59310-515 included in the NDC Directory?

    Yes, Armonair Digihaler with product code 59310-515 is active and included in the NDC Directory. The product was first marketed by Teva Respiratory, Llc on September 15, 2020 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 59310-515-08?

    The 11-digit format is 59310051508. 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 5-3-2 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
    5-3-259310-515-085-4-259310-0515-08