Omalizumab Injection, Solution
NDC Package 17088-0282-1

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.

Omalizumab injection is omalizumab is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma that is due to year-round allergens. This formulation utilizes a injection, solution delivery system. Marketed by Novartis Pharma Stein Ag, this product is identified by NDC 17088-0282.

Identification & Billing

NDC Package Code
17088-0282-1
Package Description
2 mL in 1 SYRINGE, GLASS
Product Code
17088-0282
11-Digit Billing Format
17088028201

Clinical Specifications

Proprietary Name
Omalizumab
Non-Proprietary Name
Omalizumab
Substance Name
Omalizumab
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Active Ingredient(s)
OMALIZUMAB 300 mg/2mL
Usage Information
Omalizumab is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma that is due to year-round allergens. Controlling symptoms of asthma helps you maintain your normal activities and cuts down on time lost from work or school. Omalizumab is also used to treat hives from an unknown cause (chronic idiopathic urticaria-CIU). This medication must be used regularly to be effective. It does not work right away. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, salbutamol) as prescribed.

Regulatory & Marketing

Labeler Name
Novartis Pharma Stein Ag
Product Type
Human Prescription Drug
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
08-18-2023
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 17088-0282-1 identifies a specific commercial package of 2 ml in 1 syringe, glass of Omalizumab (UNFINISHED drug), a human prescription drug labeled by Novartis Pharma Stein Ag. This injection, solution is formulated for use and contains omalizumab 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 Novartis Pharma Stein Ag on August 18, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Omalizumab is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma that is due to year-round allergens. Controlling symptoms of asthma helps you maintain your normal activities and cuts down on time lost from work or school. Omalizumab is also used to treat hives from an unknown cause (chronic idiopathic urticaria-CIU). This medication must be used regularly to be effective. It does not work right away. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, salbutamol) as prescribed.

How is this Novartis Pharma Stein Ag product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17088028201. 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)
17088-0282-1
11-Digit CMS (5-4-2)
17088-0282-01

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