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  5. NDC Package Code: 0363-0653-03 Azelastine Hydrochloride

NDC Package 0363-0653-03 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:
0363-0653-03
Package Description:
1 BOTTLE, SPRAY in 1 CARTON / 60 SPRAY, METERED in 1 BOTTLE, SPRAY (0363-0653-01)
Product Code:
0363-0653
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 useuse the sprayprime bottle again if not used for 3 or more daysclean the spray nozzle if it gets clogged adults and children 12 years and older This product may be used either once or twice a day: once daily: use 2 sprays in each nostril; ORtwice daily: use 1 or 2 sprays in each nostril every 12 hoursdo not use more than 4 sprays in each nostril in a 24 hour period children 6 years to 11 years an adult should supervise use1 spray in each nostril every 12 hoursdo not use more than 2 sprays in each nostril in a 24 hour period children under 6 years do not use
11-Digit NDC Billing Format:
00363065303
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:
Walgreens
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:
ANDA216421
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
07-01-2025
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
0363-0653-041 BOTTLE, SPRAY in 1 CARTON / 120 SPRAY, METERED in 1 BOTTLE, SPRAY (0363-0653-02)

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0363-0653-03?

The NDC Packaged Code 0363-0653-03 is assigned to a package of 1 bottle, spray in 1 carton / 60 spray, metered in 1 bottle, spray (0363-0653-01) of Azelastine Hydrochloride, a human over the counter drug labeled by Walgreens. The product's dosage form is spray, metered and is administered via nasal form.

Is NDC 0363-0653 included in the NDC Directory?

Yes, Azelastine Hydrochloride with product code 0363-0653 is active and included in the NDC Directory. The product was first marketed by Walgreens on July 01, 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 0363-0653-03?

The 11-digit format is 00363065303. 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 4-4-2 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
4-4-20363-0653-035-4-200363-0653-03