Albuterol Sulfate Solution
NDC Package 64980-643-03

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

Package Information

Albuterol Sulfate solution 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 solution delivery system. Marketed by Rising Pharma Holdings, Inc, this product is identified by NDC 64980-643 and is authorized under FDA application ANDA076355.

Identification & Billing

NDC Package Code
64980-643-03
Package Description
30 POUCH in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
Product Code
64980-643
11-Digit Billing Format
64980064303
RxNorm Crosswalk
  • RxCUI: 351136 - albuterol sulfate 0.042 % (1.25 MG/3 ML) Inhalation Solution
  • RxCUI: 351136 - albuterol 0.417 MG/ML Inhalation Solution
  • RxCUI: 351136 - albuterol 0.042 % (1.25 MG/3 ML) Inhalation Solution
  • RxCUI: 351136 - albuterol 1.25 MG (albuterol sulfate 1.5 MG) per 3 ML Inhalation Solution
  • RxCUI: 351137 - albuterol sulfate 0.021 % (0.63 MG/3 ML) Inhalation Solution

Clinical Specifications

Proprietary Name
Albuterol Sulfate
Non-Proprietary Name
Albuterol Sulfate
Substance Name
Albuterol Sulfate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
ALBUTEROL SULFATE .63 mg/3mL
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
Rising Pharma Holdings, Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA076355
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-14-2025
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 64980-643-03 identifies a specific commercial package of 30 pouch in 1 carton / 1 vial, single-dose in 1 pouch / 3 ml in 1 vial, single-dose of Albuterol Sulfate, a human prescription drug labeled by Rising Pharma Holdings, Inc. This solution 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 Rising Pharma Holdings, Inc on April 14, 2025. 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 Rising Pharma Holdings, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64980064303. 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)
64980-643-03
11-Digit CMS (5-4-2)
64980-0643-03

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