Serevent
NDC 68258-8961
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Serevent is a NDA-approved product labeled by Dispensing Solutions, Inc.. 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 is supplied as a product. This product entry covers the primary NDC 68258-8961 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
68258-8961
Proprietary Name:
Serevent Diskus
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
68258
Product Label ID:
FDA Application Number: [6]
NDA020692
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
11-25-1997
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure Chart
Product Details
What is NDC 68258-8961?
The NDC code 68258-8961 is assigned by the FDA to the product Serevent Diskus. This pharmaceutical product is labeled by Dispensing Solutions, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 68258-8961-6. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
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
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- SALMETEROL XINAFOATE (UNII: 6EW8Q962A5)
- SALMETEROL (UNII: 2I4BC502BT) (Active Moiety)
Which are the Inactive Ingredients associated UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- LACTOSE (UNII: J2B2A4N98G)
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- 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]
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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
