Flonase Spray, Metered
NDC Package 0135-0576-16

11-digit billing NDC: 00135057616 · Billing unit: ML
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Flonase (fluticasone propionate) sprays is •read the Quick Start Guide for how to:oprime the bottleouse the sprayoclean the spray nozzle•shake gently before each use•use this product only once a day•do not use more than directedADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER•Week 1- use 2 sprays in each nostril once daily•Week 2 through 6 months- use 1 or 2 sprays in each nostril once daily, as needed to treat your symptoms•After 6 months of daily use – ask your doctor if you can keep usingCHILDREN 4 TO 11 YEARS OF AGE•the growth rate of some children may be slower while using this product. This formulation utilizes a spray, metered delivery system. Marketed by Haleon Us Holdings Llc, this product is identified by NDC 0135-0576 and is authorized under FDA application NDA205434.

Identification & Billing

NDC Package Code
0135-0576-16
Package Description
3 BOTTLE in 1 PACKAGE / 144 SPRAY, METERED in 1 BOTTLE
Product Code
0135-0576
11-Digit Billing Format
00135057616
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1797907 - fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797907 - fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797933 - FLONASE 50 MCG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797933 - fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray [Flonase]
  • RxCUI: 1797933 - Flonase 0.05 MG/ACTUAT Metered Dose Nasal Spray

Clinical Specifications

Proprietary Name
Flonase Allergy Relief
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 50 ug/1
Pharmacologic Class
Usage Information
•read the Quick Start Guide for how to:oprime the bottleouse the sprayoclean the spray nozzle•shake gently before each use•use this product only once a day•do not use more than directedADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER•Week 1- use 2 sprays in each nostril once daily•Week 2 through 6 months- use 1 or 2 sprays in each nostril once daily, as needed to treat your symptoms•After 6 months of daily use – ask your doctor if you can keep usingCHILDREN 4 TO 11 YEARS OF AGE•the growth rate of some children may be slower while using this product. Children should use for the shortest amount of time necessary to achieve symptom relief. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year.•an adult should supervise use•use 1 spray in each nostril once dailyCHILDREN UNDER 4 YEARS OF AGE•do not use

Regulatory & Marketing

Labeler Name
Haleon Us Holdings Llc
Product Type
Human Otc Drug
FDA Application #
NDA205434
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-04-2014
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0135-0576). Click a package code to view its specific billing and regulatory data.

0135-0576-01
1 BOTTLE in 1 CARTON / 30 SPRAY, METERED in 1 BOTTLE
0135-0576-02
1 BOTTLE in 1 PACKAGE / 60 SPRAY, METERED in 1 BOTTLE
0135-0576-03
1 BOTTLE in 1 PACKAGE / 120 SPRAY, METERED in 1 BOTTLE
0135-0576-04
3 BOTTLE in 1 PACKAGE / 120 SPRAY, METERED in 1 BOTTLE
0135-0576-12
2 BOTTLE in 1 PACKAGE / 120 SPRAY, METERED in 1 BOTTLE
0135-0576-14
1 BOTTLE in 1 PACKAGE / 144 SPRAY, METERED in 1 BOTTLE
0135-0576-15
2 BOTTLE in 1 PACKAGE / 144 SPRAY, METERED in 1 BOTTLE
0135-0576-17
1 BOTTLE in 1 PACKAGE / 72 SPRAY, METERED in 1 BOTTLE
0135-0576-18
1 BOTTLE in 1 PACKAGE / 90 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 0135-0576-16 identifies a specific commercial package of 3 bottle in 1 package / 144 spray, metered in 1 bottle of Flonase Allergy Relief, a human over the counter drug labeled by Haleon Us Holdings Llc. 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 Haleon Us Holdings Llc on December 04, 2014. The current certification is valid through December 31, 2026.

How is this Haleon Us Holdings Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00135057616. 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 (4-4-2)
0135-0576-16
11-Digit CMS (5-4-2)
00135-0576-16

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