Fluticasone Propionate Cream
NDC Package 21922-075-07

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

Fluticasone Propionate cream 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 cream delivery system. Marketed by Encube Ethicals, Inc., this product is identified by NDC 21922-075 and is authorized under FDA application ANDA076633.

Identification & Billing

NDC Package Code
21922-075-07
Package Description
1 TUBE in 1 CARTON / 60 g in 1 TUBE
Product Code
21922-075
11-Digit Billing Format
21922007507
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
60 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fluticasone Propionate
Non-Proprietary Name
Fluticasone Propionate
Substance Name
Fluticasone Propionate
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
FLUTICASONE PROPIONATE .5 mg/g
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
Encube Ethicals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA076633
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-18-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (21922-075). Click a package code to view its specific billing and regulatory data.

21922-075-04
1 TUBE in 1 CARTON / 15 g in 1 TUBE
21922-075-05
1 TUBE in 1 CARTON / 30 g in 1 TUBE

* 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 21922-075-07 identifies a specific commercial package of 1 tube in 1 carton / 60 g in 1 tube of Fluticasone Propionate, a human prescription drug labeled by Encube Ethicals, Inc.. This product is billed per "GM" gram and contains an estimated amount of 60 billable units per package. This cream is formulated for topical 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 Encube Ethicals, Inc. on October 18, 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 Encube Ethicals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21922007507. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 60 total billable units per package. 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)
21922-075-07
11-Digit CMS (5-4-2)
21922-0075-07

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