Ciclesonide Powder
NDC Package 53104-7633-1

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.

Ciclesonide powders is ciclesonide is used to prevent and reduce the symptoms (wheezing and shortness of breath) caused by asthma. This formulation utilizes a powder delivery system. Marketed by Cipla Ltd., this product is identified by NDC 53104-7633.

Identification & Billing

NDC Package Code
53104-7633-1
Package Description
25 kg in 1 CONTAINER
Product Code
53104-7633
11-Digit Billing Format
53104763301

Clinical Specifications

Proprietary Name
Ciclesonide
Non-Proprietary Name
Ciclesonide
Substance Name
Ciclesonide
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
CICLESONIDE 25 kg/25kg
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
Cipla Ltd.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-01-2017
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 53104-7633-1 identifies a specific commercial package of 25 kg in 1 container of Ciclesonide (UNFINISHED drug), a bulk ingredient labeled by Cipla Ltd.. This powder is formulated for use and contains ciclesonide 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 Cipla Ltd. on January 01, 2017. The current certification is valid through December 31, 2026.

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 Cipla Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53104763301. 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)
53104-7633-1
11-Digit CMS (5-4-2)
53104-7633-01

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