Azelastine Spray, Metered
NDC Package 67877-477-50

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

Package Information

Azelastine sprays is azelastine HCl Nasal 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. This formulation utilizes a spray, metered delivery system. Marketed by Ascend Laboratories, Llc, this product is identified by NDC 67877-477 and is authorized under FDA application ANDA208156.

Identification & Billing

NDC Package Code
67877-477-50
Package Description
1 SPRAY, METERED in 1 BOTTLE
Product Code
67877-477
11-Digit Billing Format
67877047750
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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
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 137 ug/1
Pharmacologic Class
Usage Information
Azelastine HCl Nasal 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
Ascend Laboratories, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA208156
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-18-2017
Listing Expiration
12-31-2027
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 67877-477-50 identifies a specific commercial package of 1 spray, metered in 1 bottle of Azelastine, a human prescription drug labeled by Ascend Laboratories, 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 Ascend Laboratories, Llc on August 18, 2017. The current certification is valid through December 31, 2027.

How is this Ascend Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67877047750. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
67877-477-50
11-Digit CMS (5-4-2)
67877-0477-50

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