Azelastine Hcl Spray, Metered
NDC Package 69238-2147-3

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Azelastine Hcl (azelastine) sprays is a medication used to relieve nasal symptoms such as runny/itching/stuffy nose, sneezing, and post-nasal drip caused by allergies or other conditions. This formulation utilizes a spray, metered delivery system. Marketed by Amneal Pharmaceuticals Ny Llc, this product is identified by NDC 69238-2147 and is authorized under FDA application ANDA216576.

Identification & Billing

NDC Package Code
69238-2147-3
Package Description
200 CARTON in 1 BOTTLE / 1 SPRAY, METERED in 1 CARTON
Product Code
69238-2147
11-Digit Billing Format
69238214703
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 Hcl
Non-Proprietary Name
Azelastine
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
This medication is used to relieve nasal symptoms such as runny/itching/stuffy nose, sneezing, and post-nasal drip caused by allergies or other conditions. Azelastine belongs to a class of drugs known as antihistamines. It works by blocking certain natural substances called histamines that are responsible for nasal symptoms.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Ny Llc
Product Type
Human Otc Drug
FDA Application #
ANDA216576
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-07-2024
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69238-2147-3 identifies a specific commercial package of 200 carton in 1 bottle / 1 spray, metered in 1 carton of Azelastine Hcl, a human over the counter drug labeled by Amneal Pharmaceuticals Ny 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 Amneal Pharmaceuticals Ny Llc on June 07, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to relieve nasal symptoms such as runny/itching/stuffy nose, sneezing, and post-nasal drip caused by allergies or other conditions. Azelastine belongs to a class of drugs known as antihistamines. It works by blocking certain natural substances called histamines that are responsible for nasal symptoms.

How is this Amneal Pharmaceuticals Ny Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69238214703. 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)
69238-2147-3
11-Digit CMS (5-4-2)
69238-2147-03

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