Serevent
NDC Package 68258-8961-6

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Serevent 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). Marketed by Dispensing Solutions, Inc., this product is identified by NDC 68258-8961 and is authorized under FDA application NDA020692.

Identification & Billing

NDC Package Code
68258-8961-6
Package Description
60 POWDER, METERED in 1 INHALER
Product Code
11-Digit Billing Format
68258896106
RxNorm Crosswalk
  • RxCUI: 866048 - salmeterol 50 MCG/INHAL Dry Powder Inhaler, 60 Bisters
  • RxCUI: 866048 - 60 ACTUAT salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler
  • RxCUI: 866048 - salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 Actuat
  • RxCUI: 866049 - Serevent Diskus 50 MCG/INHAL Dry Powder Inhaler, 60 Blisters
  • RxCUI: 866049 - 60 ACTUAT salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Serevent]

Clinical Specifications

Proprietary Name
Serevent Diskus
Dosage Form
-
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
Dispensing Solutions, Inc.
FDA Application #
NDA020692
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-25-1997
Listing Expiration
12-31-2017
Exclude Flag
I
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 68258-8961-6 identifies a specific commercial package of 60 powder, metered in 1 inhaler of Serevent Diskus, labeled by Dispensing Solutions, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Dispensing Solutions, Inc. on November 25, 1997. The current certification is valid through December 31, 2017.

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 Dispensing Solutions, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68258896106. 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)
68258-8961-6
11-Digit CMS (5-4-2)
68258-8961-06

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