Fluticasone Propionate Spray, Metered
NDC Package 68196-503-01

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

Package Information

Fluticasone Propionate sprays is fluticasone is used to relieve seasonal and year-round allergic and non-allergic nasal symptoms, such as stuffy/runny nose, itching, and sneezing. This formulation utilizes a spray, metered delivery system. Marketed by Sam's West, Inc, this product is identified by NDC 68196-503 and is authorized under FDA application ANDA208150.

Identification & Billing

NDC Package Code
68196-503-01
Package Description
1 BOTTLE, SPRAY in 1 CARTON / 144 SPRAY, METERED in 1 BOTTLE, SPRAY (68196-503-02)
Product Code
68196-503
11-Digit Billing Format
68196050301
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
Fluticasone is used to relieve seasonal and year-round allergic and non-allergic nasal symptoms, such as stuffy/runny nose, itching, and sneezing. It can also help relieve allergy eye symptoms such as itchy, watery eyes. This medication belongs to a class of drugs known as corticosteroids. It works in your nose to block the effects of substances that cause allergies (such as pollen, pet dander, dust mites, mold) and to reduce swelling.

Regulatory & Marketing

Labeler Name
Sam's West, Inc
Product Type
Human Otc Drug
FDA Application #
ANDA208150
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-01-2025
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 68196-503-01 identifies a specific commercial package of 1 bottle, spray in 1 carton / 144 spray, metered in 1 bottle, spray (68196-503-02) of Fluticasone Propionate, a human over the counter drug labeled by Sam's West, 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 Sam's West, Inc on July 01, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Fluticasone is used to relieve seasonal and year-round allergic and non-allergic nasal symptoms, such as stuffy/runny nose, itching, and sneezing. It can also help relieve allergy eye symptoms such as itchy, watery eyes. This medication belongs to a class of drugs known as corticosteroids. It works in your nose to block the effects of substances that cause allergies (such as pollen, pet dander, dust mites, mold) and to reduce swelling.

How is this Sam's West, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68196050301. 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)
68196-503-01
11-Digit CMS (5-4-2)
68196-0503-01

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