Levalbuterol Solution
NDC Package 65862-944-25

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

Package Information

Levalbuterol solution is levalbuterol inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. This formulation utilizes a solution delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 65862-944 and is authorized under FDA application ANDA207625.

Identification & Billing

NDC Package Code
65862-944-25
Package Description
5 POUCH in 1 CARTON / 5 VIAL, SINGLE-DOSE in 1 POUCH (65862-944-05) / 3 mL in 1 VIAL, SINGLE-DOSE
Product Code
65862-944
11-Digit Billing Format
65862094425
RxNorm Crosswalk
  • RxCUI: 242754 - levalbuterol HCl 1.25 MG in 3 ML Inhalation Solution
  • RxCUI: 242754 - levalbuterol 0.417 MG/ML Inhalation Solution
  • RxCUI: 242754 - levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation Solution
  • RxCUI: 311286 - levalbuterol HCl 0.63 MG in 3 ML Inhalation Solution
  • RxCUI: 311286 - levalbuterol 0.21 MG/ML Inhalation Solution

Clinical Specifications

Proprietary Name
Levalbuterol
Non-Proprietary Name
Levalbuterol
Substance Name
Levalbuterol Hydrochloride
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)
LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL
Pharmacologic Class
Usage Information
Levalbuterol inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.

Regulatory & Marketing

Labeler Name
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA207625
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-30-2016
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 65862-944-25 identifies a specific commercial package of 5 pouch in 1 carton / 5 vial, single-dose in 1 pouch (65862-944-05) / 3 ml in 1 vial, single-dose of Levalbuterol, a human prescription drug labeled by Aurobindo Pharma Limited. This solution is formulated for respiratory (inhalation) use and contains levalbuterol hydrochloride 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 Aurobindo Pharma Limited on December 30, 2016. The current certification is valid through December 31, 2026.

How is this Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65862094425. 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)
65862-944-25
11-Digit CMS (5-4-2)
65862-0944-25

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