Omnaris
NDC Package 63402-701-01

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Omnaris is a medication used to treat symptoms of the nose (stuffiness or congestion, runny nose, itching, and sneezing) caused by seasonal and year-round nasal allergies. Marketed by Sunovion Pharmaceuticals Inc., this product is identified by NDC 63402-701 and is authorized under FDA application NDA022004.

Identification & Billing

NDC Package Code
63402-701-01
Package Description
1 POUCH in 1 CARTON / 1 BOTTLE, SPRAY in 1 POUCH / 120 SPRAY in 1 BOTTLE, SPRAY
Product Code
63402-701
11-Digit Billing Format
63402070101
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.

Clinical Specifications

Proprietary Name
Omnaris
Dosage Form
-
Usage Information
This medication is used to treat symptoms of the nose (stuffiness or congestion, runny nose, itching, and sneezing) caused by seasonal and year-round nasal allergies. Ciclesonide works by reducing the swelling (inflammation) of the nasal passages. It belongs to the class of drugs known as corticosteroids.

Regulatory & Marketing

Labeler Name
Sunovion Pharmaceuticals Inc.
FDA Application #
NDA022004
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-01-2008
End Marketing Date
12-01-2019
Listing Expiration
12-01-2019
Exclude Flag
D
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 (63402-701). Click a package code to view its specific billing and regulatory data.

63402-701-02
1 POUCH in 1 CARTON / 1 BOTTLE, SPRAY in 1 POUCH / 60 SPRAY in 1 BOTTLE, SPRAY

* 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 63402-701-01 identifies a specific commercial package of 1 pouch in 1 carton / 1 bottle, spray in 1 pouch / 120 spray in 1 bottle, spray of Omnaris, labeled by Sunovion Pharmaceuticals 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 Sunovion Pharmaceuticals Inc. on March 01, 2008. The current certification is valid through December 01, 2019.

What are the primary indications for this medication?

This medication is used to treat symptoms of the nose (stuffiness or congestion, runny nose, itching, and sneezing) caused by seasonal and year-round nasal allergies. Ciclesonide works by reducing the swelling (inflammation) of the nasal passages. It belongs to the class of drugs known as corticosteroids.

How is this Sunovion Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63402070101. 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)
63402-701-01
11-Digit CMS (5-4-2)
63402-0701-01

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