Salmeterol Xinafoate Powder
NDC Package 14501-0045-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

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.

Salmeterol Xinafoate powders is salmeterol is used as a long-term (maintenance) treatment to prevent or decrease wheezing and trouble breathing caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). This formulation utilizes a powder delivery system. Marketed by Msn Laboratories Private Limited, this product is identified by NDC 14501-0045.

Identification & Billing

NDC Package Code
14501-0045-2
Package Description
50 kg in 1 DRUM
Product Code
11-Digit Billing Format
14501004502

Clinical Specifications

Proprietary Name
Salmeterol Xinafoate
Non-Proprietary Name
Salmeterol Xinafoate
Substance Name
Salmeterol Xinafoate
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)
Usage Information
Salmeterol is used as a long-term (maintenance) treatment to prevent or decrease wheezing and trouble breathing caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). It should only be used long-term if your asthma symptoms are not controlled by your other asthma medications (such as inhaled corticosteroids). Salmeterol must not be used alone to treat asthma. (See also Warning section.) It is also used to prevent asthma brought on by exercise (bronchospasm). Salmeterol 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 medication does not work right away and should not be used for sudden attacks of breathing trouble. Your doctor must prescribe a quick-relief medicine/inhaler (e.g., albuterol) for sudden shortness of breath/asthma attacks while you are on this medication. You should always have a quick-relief inhaler with you. Consult your doctor or pharmacist for more details. This medication should be used in combination with other medications such as long-acting inhaled corticosteroids. However, it should not be used with other long-acting inhaled beta agonists (e.g., formoterol, combination salmeterol/fluticasone) since this may increase your risk for side effects. It is recommended that children and teenagers, who need to use salmeterol to treat their asthma, should use a combination salmeterol/fluticasone product. Check with your child's doctor to see if this product is the right product for your child. In patients with asthma, this medication should not be used when breathing problems can be controlled with inhaled corticosteroids (e.g., flunisolide, fluticasone) and occasional

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
03-29-2010
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 14501-0045-2 identifies a specific commercial package of 50 kg in 1 drum of Salmeterol Xinafoate (UNFINISHED drug), a bulk ingredient labeled by Msn Laboratories Private Limited. This powder is formulated for use and contains salmeterol xinafoate 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 March 29, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Salmeterol is used as a long-term (maintenance) treatment to prevent or decrease wheezing and trouble breathing caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). It should only be used long-term if your asthma symptoms are not controlled by your other asthma medications (such as inhaled corticosteroids). Salmeterol must not be used alone to treat asthma. (See also Warning section.) It is also used to prevent asthma brought on by exercise (bronchospasm). Salmeterol 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 medication does not work right away and should not be used for sudden attacks of breathing trouble. Your doctor must prescribe a quick-relief medicine/inhaler (e.g., albuterol) for sudden shortness of breath/asthma attacks while you are on this medication. You should always have a quick-relief inhaler with you. Consult your doctor or pharmacist for more details. This medication should be used in combination with other medications such as long-acting inhaled corticosteroids. However, it should not be used with other long-acting inhaled beta agonists (e.g., formoterol, combination salmeterol/fluticasone) since this may increase your risk for side effects. It is recommended that children and teenagers, who need to use salmeterol to treat their asthma, should use a combination salmeterol/fluticasone product. Check with your child's doctor to see if this product is the right product for your child. In patients with asthma, this medication should not be used when breathing problems can be controlled with inhaled corticosteroids (e.g., flunisolide, fluticasone) and occasional

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: 14501004502. 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)
14501-0045-2
11-Digit CMS (5-4-2)
14501-0045-02

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