Azelastine Hydrochloride And Fluticasone Propionate Spray, Metered
NDC Package 0378-3458-23

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

Package Information

Azelastine Hydrochloride And Fluticasone Propionate sprays is none. This formulation utilizes a spray, metered delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-3458 and is authorized under FDA application NDA202236.

Identification & Billing

NDC Package Code
0378-3458-23
Package Description
1 BOTTLE in 1 BOX / 120 SPRAY, METERED in 1 BOTTLE
Product Code
0378-3458
11-Digit Billing Format
00378345823
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

Clinical Specifications

Proprietary Name
Azelastine Hydrochloride And Fluticasone Propionate
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
None.

Regulatory & Marketing

Labeler Name
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA202236
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
04-14-2020
End Marketing Date
02-28-2027
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 0378-3458-23 identifies a specific commercial package of 1 bottle in 1 box / 120 spray, metered in 1 bottle of Azelastine Hydrochloride And Fluticasone Propionate, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. 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 Mylan Pharmaceuticals Inc. on April 14, 2020.

How is this Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378345823. 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)
0378-3458-23
11-Digit CMS (5-4-2)
00378-3458-23

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