Fluticasone Propionate Aerosol, Metered
NDC Package 53873-079-01

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

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.

Fluticasone Propionate aerosols is fluticasone is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. This formulation utilizes a aerosol, metered delivery system. Marketed by Bora Pharmaceutical Services Inc., this product is identified by NDC 53873-079.

Identification & Billing

NDC Package Code
53873-079-01
Package Description
100 BOTTLE in 1 CASE / 72 AEROSOL, METERED in 1 BOTTLE
Product Code
53873-079
11-Digit Billing Format
53873007901

Clinical Specifications

Proprietary Name
Fluticasone Propionate
Non-Proprietary Name
Fluticasone Propionate
Substance Name
Fluticasone Propionate
Dosage Form
Aerosol, Metered - A pressurized dosage form consisting of metered dose valves which allow for the delivery of a uniform quantity of spray upon each activation.
Active Ingredient(s)
FLUTICASONE PROPIONATE 50 ug/1
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.

Regulatory & Marketing

Labeler Name
Bora Pharmaceutical Services Inc.
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
12-04-2014
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (53873-079). Click a package code to view its specific billing and regulatory data.

53873-079-00
100 BOTTLE in 1 CASE / 60 AEROSOL, METERED in 1 BOTTLE
53873-079-02
100 BOTTLE in 1 CASE / 90 AEROSOL, METERED in 1 BOTTLE
53873-079-04
100 BOTTLE in 1 CASE / 144 AEROSOL, METERED in 1 BOTTLE

* 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 53873-079-01 identifies a specific commercial package of 100 bottle in 1 case / 72 aerosol, metered in 1 bottle of Fluticasone Propionate (UNFINISHED drug), drug for further processing labeled by Bora Pharmaceutical Services Inc.. This aerosol, metered is formulated for use and contains fluticasone propionate 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 Bora Pharmaceutical Services Inc. on December 04, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Bora Pharmaceutical Services Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53873007901. 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)
53873-079-01
11-Digit CMS (5-4-2)
53873-0079-01

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