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  5. NDC Package Code: 58602-020-51 Azelastine Hydrochloride

NDC Package 58602-020-51 Azelastine Hydrochloride

Spray, Metered Nasal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
58602-020-51
Package Description:
1 BOTTLE, SPRAY in 1 CARTON / 60 SPRAY, METERED in 1 BOTTLE, SPRAY
Product Code:
58602-020
Proprietary Name:
Azelastine Hydrochloride
Non-Proprietary Name:
Azelastine Hydrochloride
Substance Name:
Azelastine Hydrochloride
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
11-Digit NDC Billing Format:
58602002051
NDC to 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
Product Type:
Human Otc Drug
Labeler Name:
Aurohealth Llc
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(s):
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s):
AZELASTINE HYDROCHLORIDE 205.5 ug/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA216561
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
01-27-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
58602-020-071 BOTTLE, SPRAY in 1 CARTON / 200 SPRAY, METERED in 1 BOTTLE, SPRAY
58602-020-521 BOTTLE, SPRAY in 1 CARTON / 120 SPRAY, METERED in 1 BOTTLE, SPRAY

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 58602-020-51?

The NDC Packaged Code 58602-020-51 is assigned to a package of 1 bottle, spray in 1 carton / 60 spray, metered in 1 bottle, spray of Azelastine Hydrochloride, a human over the counter drug labeled by Aurohealth Llc. The product's dosage form is spray, metered and is administered via nasal form.

Is NDC 58602-020 included in the NDC Directory?

Yes, Azelastine Hydrochloride with product code 58602-020 is active and included in the NDC Directory. The product was first marketed by Aurohealth Llc on January 27, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 58602-020-51?

The 11-digit format is 58602002051. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-258602-020-515-4-258602-0020-51