Dymista Spray, Metered
NDC Package 0037-0245-23

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

Package Information

Dymista (azelastine hydrochloride and fluticasone propionate) sprays is a medication used to relieve seasonal allergy symptoms of the nose such as stuffy/runny nose, itching, sneezing, and post-nasal drip. This formulation utilizes a spray, metered delivery system. Marketed by Viatris Specialty Llc, this product is identified by NDC 0037-0245 and is authorized under FDA application NDA202236.

Identification & Billing

NDC Package Code
0037-0245-23
Package Description
1 BOTTLE, SPRAY in 1 BOX / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
Product Code
0037-0245
11-Digit Billing Format
00037024523
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
RxNorm Crosswalk
  • RxCUI: 1797847 - azelastine HCl 137 MCG/ACTUAT / fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797847 - azelastine hydrochloride 0.137 MG/ACTUAT / fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797849 - Dymista 137/50 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797849 - azelastine hydrochloride 0.137 MG/ACTUAT / fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray [Dymista]
  • RxCUI: 1797849 - Dymista (azelastine hydrochloride 137 MCG/ACTUAT / fluticasone propionate 50 MCG/ACTUAT) Metered Dose Nasal Spray

Clinical Specifications

Proprietary Name
Dymista
Non-Proprietary Name
Azelastine Hydrochloride And Fluticasone Propionate
Substance Name
Azelastine Hydrochloride; Fluticasone Propionate
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)
Pharmacologic Class
Usage Information
This product is used to relieve seasonal allergy symptoms of the nose such as stuffy/runny nose, itching, sneezing, and post-nasal drip. It contains 2 drugs. Azelastine is an antihistamine that works by blocking certain natural substances called histamines that are responsible for allergic symptoms. Fluticasone belongs to a class of drugs known as corticosteroids. It works by reducing swelling (inflammation) in the nasal passages.

Regulatory & Marketing

Labeler Name
Viatris Specialty Llc
Product Type
Human Prescription Drug
FDA Application #
NDA202236
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-01-2016
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 0037-0245-23 identifies a specific commercial package of 1 bottle, spray in 1 box / 120 spray, metered in 1 bottle, spray of Dymista, a human prescription drug labeled by Viatris Specialty Llc. This spray, metered is formulated for nasal use and contains azelastine hydrochloride; fluticasone propionate 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 Viatris Specialty Llc on October 01, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This product is used to relieve seasonal allergy symptoms of the nose such as stuffy/runny nose, itching, sneezing, and post-nasal drip. It contains 2 drugs. Azelastine is an antihistamine that works by blocking certain natural substances called histamines that are responsible for allergic symptoms. Fluticasone belongs to a class of drugs known as corticosteroids. It works by reducing swelling (inflammation) in the nasal passages.

How is this Viatris Specialty Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00037024523. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. 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 (4-4-2)
0037-0245-23
11-Digit CMS (5-4-2)
00037-0245-23

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