Asmanex Hfa Aerosol
NDC Package 78206-113-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Asmanex Hfa (mometasone furoate) aerosols is mometasone is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. This formulation utilizes a aerosol delivery system. Marketed by Organon Llc, this product is identified by NDC 78206-113 and is authorized under FDA application NDA205641.

Identification & Billing

NDC Package Code
78206-113-01
Package Description
1 CANISTER in 1 CARTON / 120 AEROSOL in 1 CANISTER
Product Code
78206-113
11-Digit Billing Format
78206011301
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
RxNorm Crosswalk
  • RxCUI: 1536142 - mometasone furoate 100 MCG/INHAL Metered Dose Inhaler, 120 ACTUAT
  • RxCUI: 1536142 - 120 ACTUAT mometasone furoate 0.1 MG/ACTUAT Metered Dose Inhaler
  • RxCUI: 1536142 - 120 ACTUAT mometasone furoate 100 MCG/ACTUAT Metered Dose Inhaler
  • RxCUI: 1536144 - Asmanex HFA 100 MCG/INHAL Metered Dose Inhaler, 120 ACTUAT
  • RxCUI: 1536144 - 120 ACTUAT mometasone furoate 0.1 MG/ACTUAT Metered Dose Inhaler [Asmanex]

Clinical Specifications

Proprietary Name
Asmanex Hfa
Non-Proprietary Name
Mometasone Furoate
Substance Name
Mometasone Furoate
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
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
MOMETASONE FUROATE 200 ug/1
Pharmacologic Class
Usage Information
Mometasone 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. Mometasone 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.

Regulatory & Marketing

Labeler Name
Organon Llc
Product Type
Human Prescription Drug
FDA Application #
NDA205641
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-01-2021
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (78206-113). Click a package code to view its specific billing and regulatory data.

78206-113-59
1 CANISTER in 1 CARTON / 120 AEROSOL in 1 CANISTER

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 78206-113-01 identifies a specific commercial package of 1 canister in 1 carton / 120 aerosol in 1 canister of Asmanex Hfa, a human prescription drug labeled by Organon Llc. This aerosol is formulated for respiratory (inhalation) use and contains mometasone furoate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Organon Llc on June 01, 2021. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Mometasone 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. Mometasone 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.

How is this Organon Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78206011301. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
78206-113-01
11-Digit CMS (5-4-2)
78206-0113-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.