Levalbuterol Tartrate Powder
NDC Package 69988-0045-1

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Levalbuterol Tartrate powders 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 powder delivery system. Marketed by Catalent Micron Technologies, Inc., this product is identified by NDC 69988-0045.

Identification & Billing

NDC Package Code
69988-0045-1
Package Description
1 BAG in 1 DRUM / 2 POWDER in 1 BAG
Product Code
69988-0045
11-Digit Billing Format
69988004501

Clinical Specifications

Proprietary Name
Levalbuterol Tartrate
Non-Proprietary Name
Levalbuterol Tartrate
Substance Name
Levalbuterol Tartrate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
LEVALBUTEROL TARTRATE 1 kg/1
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
Catalent Micron Technologies, Inc.
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
11-01-2010
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 69988-0045-1 identifies a specific commercial package of 1 bag in 1 drum / 2 powder in 1 bag of Levalbuterol Tartrate (UNFINISHED drug), drug for further processing labeled by Catalent Micron Technologies, Inc.. This powder is formulated for 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 Catalent Micron Technologies, Inc. on November 01, 2010. 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 Catalent Micron Technologies, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69988004501. 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)
69988-0045-1
11-Digit CMS (5-4-2)
69988-0045-01

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