Qvar Redihaler
NDC Package 53002-3477-3

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.

Qvar Redihaler is beclomethasone is used to prevent and control symptoms (wheezing and shortness of breath) caused by asthma. Marketed by Rpk Pharmaceuticals, Inc., this product is identified by NDC 53002-3477 and is authorized under FDA application NDA207921.

Identification & Billing

NDC Package Code
53002-3477-3
Package Description
1 INHALER in 1 CARTON / 1 AEROSOL, METERED in 1 INHALER
Product Code
53002-3477
11-Digit Billing Format
53002347703
RxNorm Crosswalk
  • RxCUI: 1998771 - beclomethasone dipropionate 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUAT
  • RxCUI: 1998771 - Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.08 MG/ACTUAT Metered Dose Inhaler
  • RxCUI: 1998772 - QVAR Redihaler 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUAT
  • RxCUI: 1998772 - Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.08 MG/ACTUAT Metered Dose Inhaler [Qvar]
  • RxCUI: 1998772 - Breath-Actuated 120 ACTUAT Qvar 0.08 MG/ACTUAT Metered Dose Inhaler

Clinical Specifications

Proprietary Name
Qvar Redihaler
Dosage Form
-
Usage Information
Beclomethasone is used to prevent and control symptoms (wheezing and shortness of breath) caused by asthma. This medication belongs to a class of drugs known as corticosteroids. It works by reducing the swelling of the airways in the lungs to make breathing easier. This medication must be used regularly to prevent breathing problems (attacks of wheezing/shortness of breath). It does not work right away and should not be used to relieve an asthma attack. If an attack occurs, use your quick-relief inhaler as prescribed.

Regulatory & Marketing

Labeler Name
Rpk Pharmaceuticals, Inc.
FDA Application #
NDA207921
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-15-2018
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 53002-3477-3 identifies a specific commercial package of 1 inhaler in 1 carton / 1 aerosol, metered in 1 inhaler of Qvar Redihaler, 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 15, 2018. The current certification is valid through December 31, 2024.

What are the primary indications for this medication?

Beclomethasone is used to prevent and control symptoms (wheezing and shortness of breath) caused by asthma. This medication belongs to a class of drugs known as corticosteroids. It works by reducing the swelling of the airways in the lungs to make breathing easier. This medication must be used regularly to prevent breathing problems (attacks of wheezing/shortness of breath). It does not work right away and should not be used to relieve an asthma attack. If an attack occurs, use your quick-relief inhaler as prescribed.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53002347703. 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)
53002-3477-3
11-Digit CMS (5-4-2)
53002-3477-03

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