Proair Respiclick
NDC Package 53002-1750-1

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.

Proair Respiclick is albuterol (also known as salbutamol) is used to prevent and treat wheezing and shortness of breath caused by breathing problems (such as asthma, chronic obstructive pulmonary disease). Marketed by Rpk Pharmaceuticals, Inc., this product is identified by NDC 53002-1750 and is authorized under FDA application NDA205636.

Identification & Billing

NDC Package Code
53002-1750-1
Package Description
1 INHALER in 1 BOX / 200 POWDER, METERED in 1 INHALER
Product Code
53002-1750
11-Digit Billing Format
53002175001
RxNorm Crosswalk
  • RxCUI: 1649560 - albuterol sulfate 90 MCG/INHAL Dry Powder Inhaler, 200 Actuations
  • RxCUI: 1649560 - 200 ACTUAT albuterol 0.09 MG/ACTUAT Dry Powder Inhaler
  • RxCUI: 1649560 - albuterol 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 200 ACTUAT Dry Powder Inhaler
  • RxCUI: 1649560 - albuterol 90 MCG/ACTUAT Dry Powder Inhaler, 200 ACTUAT
  • RxCUI: 1649961 - ProAir RespiClick 90 MCG/INHAL Dry Powder Inhaler, 200 Actuations

Clinical Specifications

Proprietary Name
Proair Respiclick
Dosage Form
-
Usage Information
Albuterol (also known as salbutamol) is used to prevent and treat wheezing and shortness of breath caused by breathing problems (such as asthma, chronic obstructive pulmonary disease). It is also used to prevent asthma brought on by exercise. It is a quick-relief medication. Albuterol belongs to a class of drugs known as bronchodilators. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Controlling symptoms of breathing problems can decrease time lost from work or school.

Regulatory & Marketing

Labeler Name
Rpk Pharmaceuticals, Inc.
FDA Application #
NDA205636
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-23-2015
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 53002-1750-1 identifies a specific commercial package of 1 inhaler in 1 box / 200 powder, metered in 1 inhaler of Proair Respiclick, 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 April 23, 2015. The current certification is valid through December 31, 2024.

What are the primary indications for this medication?

Albuterol (also known as salbutamol) is used to prevent and treat wheezing and shortness of breath caused by breathing problems (such as asthma, chronic obstructive pulmonary disease). It is also used to prevent asthma brought on by exercise. It is a quick-relief medication. Albuterol belongs to a class of drugs known as bronchodilators. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Controlling symptoms of breathing problems can decrease time lost from work or school.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53002175001. 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)
53002-1750-1
11-Digit CMS (5-4-2)
53002-1750-01

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