Formoterol Fumarate Powder
NDC Package 14501-0087-2

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.

Formoterol Fumarate powders is formoterol is used as a long-term (maintenance) treatment to prevent or decrease breathing problems caused by ongoing lung diseases (chronic obstructive pulmonary disease-COPD, including chronic bronchitis and emphysema). This formulation utilizes a powder delivery system. Marketed by Msn Laboratories Private Limited, this product is identified by NDC 14501-0087.

Identification & Billing

NDC Package Code
14501-0087-2
Package Description
50 kg in 1 DRUM
Product Code
14501-0087
11-Digit Billing Format
14501008702

Clinical Specifications

Proprietary Name
Formoterol Fumarate
Non-Proprietary Name
Formoterol Fumarate
Substance Name
Formoterol Fumarate
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)
FORMOTEROL FUMARATE 1 kg/kg
Usage Information
Formoterol is used as a long-term (maintenance) treatment to prevent or decrease breathing problems caused by ongoing lung diseases (chronic obstructive pulmonary disease-COPD, including chronic bronchitis and emphysema). Formoterol belongs to the class of drugs known as long-acting inhaled beta-agonists (LABAs). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. This effect helps to reduce wheezing, coughing, and shortness of breath. This medication does not work right away and should not be used for sudden attacks of breathing trouble. Your doctor must prescribe a quick-relief inhaler (e.g., albuterol, also called salbutamol in some countries) for sudden shortness of breath while you are using formoterol. You should always have a quick-relief inhaler with you. This form of formoterol is not approved to treat asthma. People with asthma using long-acting inhaled beta agonists (such as formoterol) without also using an inhaled corticosteroid may have an increased risk of serious (sometimes fatal) breathing problems.

Regulatory & Marketing

Labeler Name
Msn Laboratories Private Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
02-28-2014
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 14501-0087-2 identifies a specific commercial package of 50 kg in 1 drum of Formoterol Fumarate (UNFINISHED drug), a bulk ingredient labeled by Msn Laboratories Private Limited. This powder is formulated for use and contains formoterol fumarate 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 Msn Laboratories Private Limited on February 28, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Formoterol is used as a long-term (maintenance) treatment to prevent or decrease breathing problems caused by ongoing lung diseases (chronic obstructive pulmonary disease-COPD, including chronic bronchitis and emphysema). Formoterol belongs to the class of drugs known as long-acting inhaled beta-agonists (LABAs). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. This effect helps to reduce wheezing, coughing, and shortness of breath. This medication does not work right away and should not be used for sudden attacks of breathing trouble. Your doctor must prescribe a quick-relief inhaler (e.g., albuterol, also called salbutamol in some countries) for sudden shortness of breath while you are using formoterol. You should always have a quick-relief inhaler with you. This form of formoterol is not approved to treat asthma. People with asthma using long-acting inhaled beta agonists (such as formoterol) without also using an inhaled corticosteroid may have an increased risk of serious (sometimes fatal) breathing problems.

How is this Msn Laboratories Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 14501008702. 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)
14501-0087-2
11-Digit CMS (5-4-2)
14501-0087-02

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