Albuterol Sulfate Aerosol, Metered
NDC Package 45802-088-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Albuterol Sulfate aerosols is albuterol (also known as salbutamol) is used to treat wheezing and shortness of breath caused by breathing problems such as asthma. This formulation utilizes a aerosol, metered delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-088 and is authorized under FDA application ANDA203760.

Identification & Billing

NDC Package Code
45802-088-01
Package Description
1 INHALER in 1 CARTON / 200 AEROSOL, METERED in 1 INHALER
Product Code
45802-088
11-Digit Billing Format
45802008801
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
RxNorm Crosswalk
  • RxCUI: 2123072 - albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAir
  • RxCUI: 2123072 - NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler
  • RxCUI: 2123072 - albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAir

Clinical Specifications

Proprietary Name
Albuterol Sulfate
Non-Proprietary Name
Albuterol Sulfate
Substance Name
Albuterol Sulfate
Dosage Form
Aerosol, Metered - A pressurized dosage form consisting of metered dose valves which allow for the delivery of a uniform quantity of spray upon each activation.
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
ALBUTEROL SULFATE 90 ug/1
Pharmacologic Class
Usage Information
Albuterol (also known as salbutamol) is used to treat wheezing and shortness of breath caused by breathing problems such as asthma. 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
Padagis Israel Pharmaceuticals Ltd
Product Type
Human Prescription Drug
FDA Application #
ANDA203760
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-26-2020
Listing Expiration
12-31-2026
Exclude Flag
N
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 45802-088-01 identifies a specific commercial package of 1 inhaler in 1 carton / 200 aerosol, metered in 1 inhaler of Albuterol Sulfate, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. This aerosol, metered is formulated for respiratory (inhalation) use and contains albuterol sulfate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Padagis Israel Pharmaceuticals Ltd on February 26, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Albuterol (also known as salbutamol) is used to treat wheezing and shortness of breath caused by breathing problems such as asthma. 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 Padagis Israel Pharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45802008801. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. 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)
45802-088-01
11-Digit CMS (5-4-2)
45802-0088-01

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