Azelastine Hydrochloride
NDC Package 53002-2279-1

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

Azelastine Hydrochloride is nasal solution (nasal spray), 0.1% (137 mcg per spray) is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. Marketed by Rpk Pharmaceuticals, Inc., this product is identified by NDC 53002-2279 and is authorized under FDA application ANDA090423.

Identification & Billing

NDC Package Code
53002-2279-1
Package Description
1 BOTTLE, SPRAY in 1 BOX / 200 SPRAY, METERED in 1 BOTTLE, SPRAY
Product Code
53002-2279
11-Digit Billing Format
53002227901
RxNorm Crosswalk
  • RxCUI: 1797867 - azelastine HCl 137 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797867 - azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal Spray

Clinical Specifications

Proprietary Name
Azelastine Hydrochloride
Dosage Form
-
Usage Information
Azelastine hydrochloride nasal solution (nasal spray), 0.1% (137 mcg per spray) is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.

Regulatory & Marketing

Labeler Name
Rpk Pharmaceuticals, Inc.
FDA Application #
ANDA090423
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-24-2012
Listing Expiration
12-31-2023
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 53002-2279-1 identifies a specific commercial package of 1 bottle, spray in 1 box / 200 spray, metered in 1 bottle, spray of Azelastine Hydrochloride, labeled by Rpk 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 Rpk Pharmaceuticals, Inc. on May 24, 2012. The current certification is valid through December 31, 2023.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53002227901. 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)
53002-2279-1
11-Digit CMS (5-4-2)
53002-2279-01

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