Alvesco
NDC Package 54868-5989-0

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Alvesco is ciclesonide is used to prevent and reduce the symptoms (wheezing and shortness of breath) caused by asthma. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5989 and is authorized under FDA application NDA021658.

Identification & Billing

NDC Package Code
54868-5989-0
Package Description
60 AEROSOL, METERED in 1 INHALER
Product Code
54868-5989
11-Digit Billing Format
54868598900
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
RxNorm Crosswalk
  • RxCUI: 799034 - ciclesonide 160 MCG/INHAL Metered Dose Inhaler, 60 Actuations
  • RxCUI: 799034 - 60 ACTUAT ciclesonide 0.16 MG/ACTUAT Metered Dose Inhaler
  • RxCUI: 799034 - ciclesonide 160 MCG/ACTUAT Metered Dose Inhaler, 60 ACTUAT
  • RxCUI: 799037 - Alvesco 160 MCG/INHAL Metered Dose Inhaler, 60 Actuations
  • RxCUI: 799037 - 60 ACTUAT ciclesonide 0.16 MG/ACTUAT Metered Dose Inhaler [Alvesco]

Clinical Specifications

Proprietary Name
Alvesco
Dosage Form
-
Usage Information
Ciclesonide is used to prevent and reduce the symptoms (wheezing and shortness of breath) caused by asthma. Controlling asthma symptoms may decrease time lost from work or school. This medication belongs to a class of drugs known as corticosteroids. It works by reducing the swelling of the airways in the lungs to make breathing easier. This medication must be taken 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 as prescribed. Keep track of how often you need to use your quick-relief inhaler, and tell your doctor. If your quick-relief inhaler does not seem to work as well, if you need to use more than usual of your quick-relief inhaler for 2 or more days in a row, or if you need to use more than one full canister of your quick-relief inhaler over a 2-month period, seek immediate medical attention.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA021658
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-19-2009
Listing Expiration
12-31-2017
Exclude Flag
I
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54868-5989-0 identifies a specific commercial package of 60 aerosol, metered in 1 inhaler of Alvesco, labeled by Physicians Total Care, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Physicians Total Care, Inc. on February 19, 2009. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

Ciclesonide is used to prevent and reduce the symptoms (wheezing and shortness of breath) caused by asthma. Controlling asthma symptoms may decrease time lost from work or school. This medication belongs to a class of drugs known as corticosteroids. It works by reducing the swelling of the airways in the lungs to make breathing easier. This medication must be taken 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 as prescribed. Keep track of how often you need to use your quick-relief inhaler, and tell your doctor. If your quick-relief inhaler does not seem to work as well, if you need to use more than usual of your quick-relief inhaler for 2 or more days in a row, or if you need to use more than one full canister of your quick-relief inhaler over a 2-month period, seek immediate medical attention.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868598900. 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 (5-4-1)
54868-5989-0
11-Digit CMS (5-4-2)
54868-5989-00

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