Omnaris Spray
NDC Package 70515-701-01

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

Package Information

Omnaris (ciclesonide) sprays 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. This formulation utilizes a spray delivery system. Marketed by Covis Pharma Us, Inc, this product is identified by NDC 70515-701 and is authorized under FDA application NDA022004.

Identification & Billing

NDC Package Code
70515-701-01
Package Description
1 POUCH in 1 CARTON / 1 BOTTLE, GLASS in 1 POUCH / 120 SPRAY in 1 BOTTLE, GLASS
Product Code
70515-701
11-Digit Billing Format
70515070101
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Omnaris
Non-Proprietary Name
Ciclesonide
Substance Name
Ciclesonide
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
CICLESONIDE 50 ug/1
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
Covis Pharma Us, Inc
Product Type
Human Prescription Drug
FDA Application #
NDA022004
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-23-2018
Listing Expiration
12-31-2026
Exclude Flag
N
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 70515-701-01 identifies a specific commercial package of 1 pouch in 1 carton / 1 bottle, glass in 1 pouch / 120 spray in 1 bottle, glass of Omnaris, a human prescription drug labeled by Covis Pharma Us, Inc. This spray is formulated for nasal 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 Covis Pharma Us, Inc on April 23, 2018. The current certification is valid through December 31, 2026.

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 Covis Pharma Us, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70515070101. 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)
70515-701-01
11-Digit CMS (5-4-2)
70515-0701-01

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