Xhance Spray, Metered
NDC Package 71143-375-99

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

Xhance (fluticasone propionate) sprays is fluticasone is used to treat certain growths in the nose (nasal polyps). This formulation utilizes a spray, metered delivery system. Marketed by Optinose Us, Inc., this product is identified by NDC 71143-375 and is authorized under FDA application NDA209022.

Identification & Billing

NDC Package Code
71143-375-99
Package Description
1 BOTTLE in 1 CARTON / 120 SPRAY, METERED in 1 BOTTLE
Product Code
71143-375
11-Digit Billing Format
71143037599
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1946583 - fluticasone propionate 93 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1946583 - fluticasone propionate 0.093 MG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1946589 - XHANCE 93 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1946589 - fluticasone propionate 0.093 MG/ACTUAT Metered Dose Nasal Spray [Xhance]
  • RxCUI: 1946589 - Xhance 0.093 MG/ACTUAT Metered Dose Nasal Spray

Clinical Specifications

Proprietary Name
Xhance
Non-Proprietary Name
Fluticasone Propionate
Substance Name
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)
FLUTICASONE PROPIONATE 93 ug/1
Pharmacologic Class
Usage Information
Fluticasone is used to treat certain growths in the nose (nasal polyps). It belongs to a class of drugs known as corticosteroids. Fluticasone works by reducing swelling (inflammation) in the nasal passages. This can help decrease symptoms such as stuffy nose.

Regulatory & Marketing

Labeler Name
Optinose Us, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA209022
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-03-2017
End Marketing Date
07-31-2028
Exclude Flag
N
Sample Package
Yes

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 (71143-375). Click a package code to view its specific billing and regulatory data.

71143-375-01
1 BOTTLE in 1 CARTON / 120 SPRAY, METERED in 1 BOTTLE
71143-375-98
1 BOTTLE in 1 CARTON / 28 SPRAY, METERED in 1 BOTTLE

* 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 71143-375-99 identifies a specific commercial package of 1 bottle in 1 carton / 120 spray, metered in 1 bottle of Xhance, a human prescription drug labeled by Optinose Us, Inc.. This spray, metered is formulated for nasal use and contains 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 Optinose Us, Inc. on October 03, 2017.

What are the primary indications for this medication?

Fluticasone is used to treat certain growths in the nose (nasal polyps). It belongs to a class of drugs known as corticosteroids. Fluticasone works by reducing swelling (inflammation) in the nasal passages. This can help decrease symptoms such as stuffy nose.

How is this Optinose Us, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71143037599. 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)
71143-375-99
11-Digit CMS (5-4-2)
71143-0375-99

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