Mometasone Furoate Aerosol
NDC Package 11517-433-31

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Mometasone Furoate aerosols is mometasone is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. This formulation utilizes a aerosol delivery system. Marketed by Kindeva Drug Delivery Limited, this product is identified by NDC 11517-433.

Identification & Billing

NDC Package Code
11517-433-31
Package Description
150 CANISTER in 1 TRAY / 120 AEROSOL in 1 CANISTER
Product Code
11517-433
11-Digit Billing Format
11517043331

Clinical Specifications

Proprietary Name
Mometasone Furoate
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).
Active Ingredient(s)
MOMETASONE FUROATE 100 ug/1
Usage Information
Mometasone is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. 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. Mometasone belongs to a class of drugs known as corticosteroids. It works by reducing the irritation and swelling of the airways. Controlling symptoms of breathing problems can decrease time lost from work or school.

Regulatory & Marketing

Labeler Name
Kindeva Drug Delivery Limited
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
04-25-2014
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 11517-433-31 identifies a specific commercial package of 150 canister in 1 tray / 120 aerosol in 1 canister of Mometasone Furoate (UNFINISHED drug), drug for further processing labeled by Kindeva Drug Delivery Limited. This aerosol is formulated for 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 Kindeva Drug Delivery Limited on April 25, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Mometasone is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. 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. Mometasone belongs to a class of drugs known as corticosteroids. It works by reducing the irritation and swelling of the airways. Controlling symptoms of breathing problems can decrease time lost from work or school.

How is this Kindeva Drug Delivery Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11517043331. 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)
11517-433-31
11-Digit CMS (5-4-2)
11517-0433-31

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