Azelastine Hydrochloride Spray, Metered
NDC Package 51316-840-01

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 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. This formulation utilizes a spray, metered delivery system. Marketed by Cvs Pharmacy, Inc, this product is identified by NDC 51316-840 and is authorized under FDA application ANDA216421.

Identification & Billing

NDC Package Code
51316-840-01
Package Description
1 BOTTLE, SPRAY in 1 CARTON / 120 SPRAY, METERED in 1 BOTTLE, SPRAY (51316-840-02)
Product Code
51316-840
11-Digit Billing Format
51316084001
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 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

Regulatory & Marketing

Labeler Name
Cvs Pharmacy, Inc
Product Type
Human Otc Drug
FDA Application #
ANDA216421
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-01-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (51316-840). Click a package code to view its specific billing and regulatory data.

51316-840-02
120 SPRAY, METERED in 1 BOTTLE, SPRAY
51316-840-03
1 BOTTLE, SPRAY in 1 CARTON / 60 SPRAY, METERED in 1 BOTTLE, SPRAY
51316-840-04
60 SPRAY, METERED in 1 BOTTLE, SPRAY
51316-840-05
2 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 51316-840-01 identifies a specific commercial package of 1 bottle, spray in 1 carton / 120 spray, metered in 1 bottle, spray (51316-840-02) of Azelastine Hydrochloride, a human over the counter drug labeled by Cvs Pharmacy, Inc. 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 Cvs Pharmacy, Inc on August 01, 2025. The current certification is valid through December 31, 2027.

How is this Cvs Pharmacy, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51316084001. 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)
51316-840-01
11-Digit CMS (5-4-2)
51316-0840-01

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