Levalbuterol Solution, Concentrate
NDC Package 65862-942-03

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

Package Information

Levalbuterol solution is levalbuterol inhalation solution (concentrate) 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, concentrate delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 65862-942 and is authorized under FDA application ANDA207628.

Identification & Billing

NDC Package Code
65862-942-03
Package Description
30 POUCH in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-942-50) / .5 mL in 1 VIAL, SINGLE-DOSE
Product Code
65862-942
11-Digit Billing Format
65862094203
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 1855389 - levalbuterol HCl concentrate 1.25 MG in 0.5 ML Inhalation Solution
  • RxCUI: 1855389 - levalbuterol 2.5 MG/ML Inhalation Solution
  • RxCUI: 1855389 - levalbuterol HCl 1.25 MG per 0.5 ML Inhalation Solution

Clinical Specifications

Proprietary Name
Levalbuterol
Non-Proprietary Name
Levalbuterol
Substance Name
Levalbuterol Hydrochloride
Dosage Form
Solution, Concentrate - A liquid preparation (i.e., a substance that flows readily in its natural state) that contains a drug dissolved in a suitable solvent or mixture of mutually miscible solvents; the drug has been strengthened by the evaporation of its nonactive parts.
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
LEVALBUTEROL HYDROCHLORIDE 1.25 mg/.5mL
Pharmacologic Class
Usage Information
Levalbuterol inhalation solution (concentrate) 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 #
ANDA207628
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-31-2017
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J7612
Source: PDAC
LEVALBUTEROL, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, CONCENTRATED FORM, 0.5 MG
HCPCS Dosage 0.5 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 65862-942-03 identifies a specific commercial package of 30 pouch in 1 carton / 1 vial, single-dose in 1 pouch (65862-942-50) / .5 ml in 1 vial, single-dose of Levalbuterol, a human prescription drug labeled by Aurobindo Pharma Limited. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This solution, concentrate 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 January 31, 2017. 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: 65862094203. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
65862-942-03
11-Digit CMS (5-4-2)
65862-0942-03

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