Azelastine Hydrochloride Spray, Metered
NDC Package 58602-020-07

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

Azelastine Hydrochloride sprays is ■ Read the User Guide for how to:     ■ prime the bottle before first use                              ■ use the spray     ■ prime bottle again if not used for 3 or more days   ■ clean the spray nozzle if it gets clogged adults and children 12 years and olderThis product may be used either once or twice a day:■ once daily: use 2 sprays in each nostril; OR■ twice daily: use 1 or 2 sprays in each nostril every 12 hours■ do not use more than 4 sprays in each nostril in a 24 hour periodchildren 6 years to 11 years■ an adult should supervise use■ 1 spray in each nostril every 12 hours■ do not use more than 2 sprays in each nostril in a 24 hour periodchildren under 6 yearsdo not use. This formulation utilizes a spray, metered delivery system. Marketed by Aurohealth Llc, this product is identified by NDC 58602-020 and is authorized under FDA application ANDA216561.

Identification & Billing

NDC Package Code
58602-020-07
Package Description
1 BOTTLE, SPRAY in 1 CARTON / 200 SPRAY, METERED in 1 BOTTLE, SPRAY
Product Code
58602-020
11-Digit Billing Format
58602002007
RxNorm Crosswalk
  • RxCUI: 1797883 - azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797883 - azelastine hydrochloride 0.206 MG/ACTUAT Metered Dose Nasal Spray

Clinical Specifications

Proprietary Name
Azelastine Hydrochloride
Non-Proprietary Name
Azelastine Hydrochloride
Substance Name
Azelastine Hydrochloride
Dosage Form
Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
AZELASTINE HYDROCHLORIDE 205.5 ug/1
Pharmacologic Class
Usage Information
■ Read the User Guide for how to:     ■ prime the bottle before first use                              ■ use the spray     ■ prime bottle again if not used for 3 or more days   ■ clean the spray nozzle if it gets clogged adults and children 12 years and olderThis product may be used either once or twice a day:■ once daily: use 2 sprays in each nostril; OR■ twice daily: use 1 or 2 sprays in each nostril every 12 hours■ do not use more than 4 sprays in each nostril in a 24 hour periodchildren 6 years to 11 years■ an adult should supervise use■ 1 spray in each nostril every 12 hours■ do not use more than 2 sprays in each nostril in a 24 hour periodchildren under 6 yearsdo not use

Regulatory & Marketing

Labeler Name
Aurohealth Llc
Product Type
Human Otc Drug
FDA Application #
ANDA216561
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-27-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (58602-020). Click a package code to view its specific billing and regulatory data.

58602-020-51
1 BOTTLE, SPRAY in 1 CARTON / 60 SPRAY, METERED in 1 BOTTLE, SPRAY
58602-020-52
1 BOTTLE, SPRAY in 1 CARTON / 120 SPRAY, METERED 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 58602-020-07 identifies a specific commercial package of 1 bottle, spray in 1 carton / 200 spray, metered in 1 bottle, spray of Azelastine Hydrochloride, a human over the counter drug labeled by Aurohealth Llc. This spray, metered is formulated for nasal use and contains azelastine hydrochloride 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 Aurohealth Llc on January 27, 2025. The current certification is valid through December 31, 2026.

How is this Aurohealth Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58602002007. 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)
58602-020-07
11-Digit CMS (5-4-2)
58602-0020-07

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