Levalbuterol Tartrate Hfa Inhalation Aerosol, Metered
NDC Package 63187-876-15

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

Package Information

Levalbuterol Tartrate Hfa Inhalation (levalbuterol tartrate) aerosols is levalbuterol is used to prevent and treat wheezing and shortness of breath caused by breathing problems (such as asthma, chronic obstructive pulmonary disease). This formulation utilizes a aerosol, metered delivery system. Marketed by Proficient Rx Lp, this product is identified by NDC 63187-876 and is authorized under FDA application NDA021730.

Identification & Billing

NDC Package Code
63187-876-15
Package Description
1 INHALER in 1 CARTON / 200 AEROSOL, METERED in 1 INHALER
Product Code
63187-876
11-Digit Billing Format
63187087615
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
RxNorm Crosswalk
  • RxCUI: 745791 - levalbuterol 45 MCG/INHAL Metered Dose Inhaler, 200 Actuations
  • RxCUI: 745791 - 200 ACTUAT levalbuterol 0.045 MG/ACTUAT Metered Dose Inhaler
  • RxCUI: 745791 - levalbuterol 0.045 MG/ACTUAT Metered Dose Inhaler, 200 ACTUAT
  • RxCUI: 745791 - levalbuterol 45 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUAT

Clinical Specifications

Proprietary Name
Levalbuterol Tartrate Hfa Inhalation
Non-Proprietary Name
Levalbuterol Tartrate
Substance Name
Levalbuterol Tartrate
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LEVALBUTEROL TARTRATE 45 ug/1
Pharmacologic Class
Usage Information
Levalbuterol is used to prevent and treat wheezing and shortness of breath caused by breathing problems (such as asthma, chronic obstructive pulmonary disease). It is a quick-relief drug. Levalbuterol 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. This drug is not approved for use in children younger than 4 years due to increased risk of side effects (such as unusual fast breathing, worsening asthma). Ask your doctor or pharmacist for details.

Regulatory & Marketing

Labeler Name
Proficient Rx Lp
Product Type
Human Prescription Drug
FDA Application #
NDA021730
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
10-01-2016
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 63187-876-15 identifies a specific commercial package of 1 inhaler in 1 carton / 200 aerosol, metered in 1 inhaler of Levalbuterol Tartrate Hfa Inhalation, a human prescription drug labeled by Proficient Rx Lp. This aerosol, metered is formulated for oral use and contains levalbuterol tartrate 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 Proficient Rx Lp on October 01, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Levalbuterol is used to prevent and treat wheezing and shortness of breath caused by breathing problems (such as asthma, chronic obstructive pulmonary disease). It is a quick-relief drug. Levalbuterol 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. This drug is not approved for use in children younger than 4 years due to increased risk of side effects (such as unusual fast breathing, worsening asthma). Ask your doctor or pharmacist for details.

How is this Proficient Rx Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63187087615. 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)
63187-876-15
11-Digit CMS (5-4-2)
63187-0876-15

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