Fluticasone Propionate
NDC Package 53002-1401-1

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Fluticasone Propionate is fluticasone is used to relieve seasonal and year-round allergic and non-allergic nasal symptoms, such as stuffy/runny nose, itching, and sneezing. Marketed by Rpk Pharmaceuticals, Inc., this product is identified by NDC 53002-1401 and is authorized under FDA application NDA021433.

Identification & Billing

NDC Package Code
53002-1401-1
Package Description
1 INHALER in 1 CARTON / 120 AEROSOL, METERED in 1 INHALER
Product Code
53002-1401
11-Digit Billing Format
53002140101
RxNorm Crosswalk
  • RxCUI: 896004 - fluticasone propionate 220 MCG/INHAL Metered Dose Inhaler, 120 Actuations
  • RxCUI: 896004 - 120 ACTUAT fluticasone propionate 0.22 MG/ACTUAT Metered Dose Inhaler
  • RxCUI: 896004 - fluticasone propionate 0.22 MG/ACTUAT Metered Dose Inhaler, 120 ACTUAT
  • RxCUI: 896004 - fluticasone propionate 220 MCG/ACTUAT Metered Dose Inhaler, 120 ACTUAT

Clinical Specifications

Proprietary Name
Fluticasone Propionate Hfa
Dosage Form
-
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
Rpk Pharmaceuticals, Inc.
FDA Application #
NDA021433
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
05-23-2022
Listing Expiration
12-31-2024
Exclude Flag
I
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 53002-1401-1 identifies a specific commercial package of 1 inhaler in 1 carton / 120 aerosol, metered in 1 inhaler of Fluticasone Propionate Hfa, labeled by Rpk Pharmaceuticals, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Rpk Pharmaceuticals, Inc. on May 23, 2022. The current certification is valid through December 31, 2024.

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 Rpk Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53002140101. 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 (5-4-1)
53002-1401-1
11-Digit CMS (5-4-2)
53002-1401-01

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