NDC Package 78206-126-02 Dulera

Mometasone Furoate And Formoterol Fumarate Dihydrate Aerosol Respiratory (inhalation) - View Billable Units, 11-Digit Format, RxNorm

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:
78206-126-02
Package Description:
1 CANISTER in 1 CARTON / 60 AEROSOL in 1 CANISTER
Product Code:
Proprietary Name:
Dulera
Non-Proprietary Name:
Mometasone Furoate And Formoterol Fumarate Dihydrate
Substance Name:
Formoterol Fumarate; Mometasone Furoate
Usage Information:
This product is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. It contains 2 medications: mometasone and formoterol. Mometasone belongs to a class of drugs known as corticosteroids. It works by reducing the irritation and swelling of the airways. Formoterol belongs to the class of drugs known as long-acting beta agonists. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Controlling symptoms of breathing problems can decrease time lost from work or school. When used alone, long-acting beta agonists (such as formoterol) may rarely increase the risk of serious (sometimes fatal) asthma-related breathing problems. However, combination inhaled corticosteroid and long-acting beta agonists, such as this product, do not increase the risk of serious asthma-related breathing problems. This product should be used when breathing problems are not well controlled with one asthma-control medication (such as inhaled corticosteroid) or if your symptoms need combination treatment. Before using this medication, it is important to learn how to use it properly. 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:
78206012602
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
  • RxCUI: 1246308 - mometasone furoate/formoterol fumarate 100/5 MCG/INHAL Metered Dose Inhaler, 120 Actuations
  • RxCUI: 1246308 - 120 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.1 MG/ACTUAT Metered Dose Inhaler
  • RxCUI: 1246308 - formoterol fumarate 0.005 MG / mometasone furoate 0.1 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT
  • RxCUI: 1246308 - formoterol fumarate 5 MCG / mometasone furoate 100 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT
  • RxCUI: 1246310 - Dulera 100/5 MCG/INHAL Metered Dose Inhaler, 120 Actuations
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Organon Llc
    Dosage Form:
    Aerosol - A product that is packaged under pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system; it is intended for topical application to the skin as well as local application into the nose (nasal aerosols), mouth (lingual aerosols), or lungs (inhalation aerosols).
    Administration Route(s):
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
  • Sample Package:
    No
    FDA Application Number:
    NDA022518
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    06-01-2021
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    78206-126-011 CANISTER in 1 CARTON / 120 AEROSOL in 1 CANISTER
    78206-126-591 CANISTER in 1 CARTON / 60 AEROSOL in 1 CANISTER

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 78206-126-02?

    The NDC Packaged Code 78206-126-02 is assigned to a package of 1 canister in 1 carton / 60 aerosol in 1 canister of Dulera, a human prescription drug labeled by Organon Llc. The product's dosage form is aerosol and is administered via respiratory (inhalation) form.

    Is NDC 78206-126 included in the NDC Directory?

    Yes, Dulera with product code 78206-126 is active and included in the NDC Directory. The product was first marketed by Organon Llc on June 01, 2021 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 NDC billing unit for package 78206-126-02?

    The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight.

    What is the 11-digit format for NDC 78206-126-02?

    The 11-digit format is 78206012602. 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
    5-3-278206-126-025-4-278206-0126-02