Ventolin
NDC Package 16590-339-08

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.

Ventolin 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 Stat Rx Usa Llc, this product is identified by NDC 16590-339 and is authorized under FDA application NDA020983.

Identification & Billing

NDC Package Code
16590-339-08
Package Description
60 AEROSOL, METERED in 1 INHALER
Product Code
16590-339
11-Digit Billing Format
16590033908
RxNorm Crosswalk
  • RxCUI: 801092 - albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for Ventolin
  • RxCUI: 801092 - NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler
  • RxCUI: 801092 - albuterol 0.09 MG/ACTUAT 60 ACTUAT Metered Dose Inhaler
  • RxCUI: 801092 - albuterol 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose Inhaler
  • RxCUI: 801095 - Ventolin HFA 90 MCG/INHAL Metered Dose Inhaler, 60 Actuations

Clinical Specifications

Proprietary Name
Ventolin Hfa
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 drug. 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
Stat Rx Usa Llc
FDA Application #
NDA020983
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-09-2006
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 16590-339-08 identifies a specific commercial package of 60 aerosol, metered in 1 inhaler of Ventolin Hfa, labeled by Stat Rx Usa Llc. 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 Stat Rx Usa Llc on June 09, 2006. The current certification is valid through December 31, 2017.

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 drug. 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 Stat Rx Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16590033908. 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)
16590-339-08
11-Digit CMS (5-4-2)
16590-0339-08

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