Fluticasone Propionate Spray, Metered
NDC Package 37835-997-31

11-digit billing NDC: 37835099731
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Fluticasone Propionate sprays is read the Quick Start Guide for how to:prime the bottleuse the sprayclean the spray nozzle shake gently before each useuse this product only once a daydo not use more than directedADULTS AND CHILDREN 12 YEARS OF AGE AND OLDERWeek 1: use 2 sprays in each nostril dailyWeek 2 through 6 months: use 1 or 2 sprays in each nostril once daily, as needed to treat symptomsAfter 6 months of daily use: ask a doctor if you can keep usingCHILDREN 4 to 11 YEARS OF AGEthe growth of some children may be slower while using this product. This formulation utilizes a spray, metered delivery system. Marketed by Bi-mart, this product is identified by NDC 37835-997 and is authorized under FDA application ANDA208150.

Identification & Billing

NDC Package Code
37835-997-31
Package Description
1 BOTTLE, SPRAY in 1 CARTON / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
Product Code
37835-997
11-Digit Billing Format
37835099731
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

Clinical Specifications

Proprietary Name
Fluticasone Propionate
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:prime the bottleuse the sprayclean the spray nozzle shake gently before each useuse this product only once a daydo not use more than directedADULTS AND CHILDREN 12 YEARS OF AGE AND OLDERWeek 1: use 2 sprays in each nostril dailyWeek 2 through 6 months: use 1 or 2 sprays in each nostril once daily, as needed to treat symptomsAfter 6 months of daily use: ask a doctor if you can keep usingCHILDREN 4 to 11 YEARS OF AGEthe growth 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 2 months a year.an adult should supervise useuse 1 spray in each nostril dailyCHILDREN UNDER 4 YEARS OF AGEdo not use

Regulatory & Marketing

Labeler Name
Bi-mart
Product Type
Human Otc Drug
FDA Application #
ANDA208150
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-17-2017
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 (37835-997). Click a package code to view its specific billing and regulatory data.

37835-997-44
1 BOTTLE, SPRAY in 1 CARTON / 144 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 37835-997-31 identifies a specific commercial package of 1 bottle, spray in 1 carton / 120 spray, metered in 1 bottle, spray of Fluticasone Propionate, a human over the counter drug labeled by Bi-mart. 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 Bi-mart on May 17, 2017. The current certification is valid through December 31, 2027.

How is this Bi-mart product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 37835099731. 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)
37835-997-31
11-Digit CMS (5-4-2)
37835-0997-31

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