Pulmicort
NDC Package 21695-291-01

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.

Pulmicort is budesonide is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. Marketed by Rebel Distributors Corp, this product is identified by NDC 21695-291 and is authorized under FDA application NDA021949.

Identification & Billing

NDC Package Code
21695-291-01
Package Description
1 INHALER in 1 CARTON / 60 AEROSOL, POWDER in 1 INHALER
Product Code
21695-291
11-Digit Billing Format
21695029101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 966527 - budesonide 90 MCG/INHAL Dry Powder Inhaler, 60 ACTUAT
  • RxCUI: 966527 - 60 ACTUAT budesonide 0.09 MG/ACTUAT Dry Powder Inhaler
  • RxCUI: 966527 - budesonide 0.09 MG/ACTUAT (0.08 MG/ACTUAT from the mouthpiece) Dry Powder Inhaler, 60 ACTUAT
  • RxCUI: 966527 - budesonide 90 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUAT
  • RxCUI: 966529 - Pulmicort Flexhaler 90 MCG/INHAL Dry Powder Inhaler, 60 ACTUAT

Clinical Specifications

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

Regulatory & Marketing

Labeler Name
Rebel Distributors Corp
FDA Application #
NDA021949
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-30-2010
Listing Expiration
12-31-2017
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 21695-291-01 identifies a specific commercial package of 1 inhaler in 1 carton / 60 aerosol, powder in 1 inhaler of Pulmicort Flexhaler, labeled by Rebel Distributors Corp. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Rebel Distributors Corp on July 30, 2010. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

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

How is this Rebel Distributors Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21695029101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
21695-291-01
11-Digit CMS (5-4-2)
21695-0291-01

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