Albuterol Sulfate Inhalant
NDC Package 68071-3902-2

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

Package Information

Albuterol Sulfate inhalants 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 inhalant delivery system. Marketed by Nucare Pharmaceuticals,inc., this product is identified by NDC 68071-3902 and is authorized under FDA application ANDA212447.

Identification & Billing

NDC Package Code
68071-3902-2
Package Description
1 INHALER in 1 CARTON / 200 INHALANT in 1 INHALER
Product Code
68071-3902
11-Digit Billing Format
68071390202
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
Inhalant - A special class of inhalations consisting of a drug or combination of drugs, that by virtue of their high vapor pressure can be carried by an air current into the nasal passage where they exert their effect; the container from which the inhalant generally is administered is known as an inhaler.
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
Nucare Pharmaceuticals,inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA212447
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-06-2024
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 68071-3902-2 identifies a specific commercial package of 1 inhaler in 1 carton / 200 inhalant in 1 inhaler of Albuterol Sulfate, a human prescription drug labeled by Nucare Pharmaceuticals,inc.. This inhalant 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 Nucare Pharmaceuticals,inc. on August 06, 2024. 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 Nucare Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071390202. 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)
68071-3902-2
11-Digit CMS (5-4-2)
68071-3902-02

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