Fluticasone Propionate And Salmeterol
NDC Package 53002-1568-1

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 And Salmeterol is the use of Fluticasone Propionate/Salmeterol DISKUS is contraindicated in the following conditions:•Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required [see Warnings and Precautions (5.2)].•Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate, salmeterol, or any of the excipients [see Warnings and Precautions (5.11), Adverse Reactions (6.3), Description (11)]. Marketed by Rpk Pharmaceuticals, Inc., this product is identified by NDC 53002-1568 and is authorized under FDA application NDA021077.

Identification & Billing

NDC Package Code
53002-1568-1
Package Description
1 INHALER in 1 CARTON / 60 POWDER in 1 INHALER
Product Code
53002-1568
11-Digit Billing Format
53002156801
RxNorm Crosswalk
  • RxCUI: 896184 - fluticasone propionate/salmeterol 100/50 MCG/INHAL Dry Powder Inhaler, 60 Blisters
  • RxCUI: 896184 - 60 ACTUAT fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler
  • RxCUI: 896184 - fluticasone propionate 0.1 MG/ACTUAT / salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler, 60 ACTUAT
  • RxCUI: 896184 - fluticasone propionate 100 MCG / salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT

Clinical Specifications

Proprietary Name
Fluticasone Propionate And Salmeterol Diskus
Dosage Form
-
Usage Information
The use of Fluticasone Propionate/Salmeterol DISKUS is contraindicated in the following conditions:•Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required [see Warnings and Precautions (5.2)].•Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate, salmeterol, or any of the excipients [see Warnings and Precautions (5.11), Adverse Reactions (6.3), Description (11)].

Regulatory & Marketing

Labeler Name
Rpk Pharmaceuticals, Inc.
FDA Application #
NDA021077
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
02-08-2019
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 53002-1568-1 identifies a specific commercial package of 1 inhaler in 1 carton / 60 powder in 1 inhaler of Fluticasone Propionate And Salmeterol Diskus, 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 February 08, 2019. The current certification is valid through December 31, 2024.

How is this Rpk Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53002156801. 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)
53002-1568-1
11-Digit CMS (5-4-2)
53002-1568-01

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