Fluticasone Propionate And Salmeterol Powder, Metered
NDC 0093-3609

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 0093-3609?
  4. Fluticasone Propionate And Salmeterol Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

Fluticasone Propionate And Salmeterol is a NDA AUTHORIZED GENERIC-approved product labeled by Teva Pharmaceuticals Usa, Inc.. This medication is typically used as a adrenergic beta2-agonists [moa]. It is supplied as a powder, metered for respiratory (inhalation) administration. This product entry covers the primary NDC 0093-3609 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0093-3609
Proprietary Name:
Fluticasone Propionate And Salmeterol
Non-Proprietary Name: [1]
Fluticasone Propionate And Salmeterol
Substance Name: [2]
Fluticasone Propionate; Salmeterol Xinafoate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications

Dosage Form:
Powder, Metered - An powder dosage form that is situated inside a container that has a mechanism to deliver a specified quantity.
Administration Route(s): [4]
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.

Labeler & Regulatory Data

Labeler Name: [5]
Teva Pharmaceuticals Usa, Inc.
Labeler Code:
0093
Product Label ID:
43a27267-2f2b-410d-9c30-9cb95f35d9a1
FDA Application Number: [6]
NDA208799
Marketing Category: [8]
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.

Marketing Timeline

Start Marketing Date: [9]
04-28-2017
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 0093-3609?

The NDC code 0093-3609 is assigned by the FDA to the product Fluticasone Propionate And Salmeterol. This pharmaceutical product is labeled by Teva Pharmaceuticals Usa, Inc. and is currently categorized as listed product. The medication is a powder, metered administered via respiratory (inhalation) route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0093-3609-82. 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?

Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler (FS MDPI) is indicated for the treatment of asthma in patients aged 12 years and older. Fluticasone Propionate/Salmeterol MDPI should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2 adrenergic agonist (LABA).Limitations of Use:Fluticasone Propionate/Salmeterol MDPI is NOT indicated for the relief of acute bronchospasm.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • FLUTICASONE PROPIONATE 232 ug/1 - A STEROID with GLUCOCORTICOID RECEPTOR activity that is used to manage the symptoms of ASTHMA; ALLERGIC RHINITIS, and ATOPIC DERMATITIS.
  • SALMETEROL XINAFOATE 14 ug/1 - A selective ADRENERGIC BETA-2 RECEPTOR agonist that functions as a BRONCHODILATOR when administered by inhalation. It is used to manage the symptoms of ASTHMA and CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

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:

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: 1918194 - fluticasone propionate/salmeterol 113/14 MCG/INHAL Dry Powder Inhaler, 60 Actuations
  • RxCUI: 1918194 - 60 ACTUAT fluticasone propionate 0.113 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder Inhaler
  • RxCUI: 1918194 - fluticasone propionate 113 MCG/ACTUAT / salmeterol xinafoate 14 MCG/ACTUAT Dry Powder Inhaler, 60 ACTUATS
  • RxCUI: 1918203 - fluticasone propionate/salmeterol 232/14 MCG/INHAL Dry Powder Inhaler, 60 Actuations
  • RxCUI: 1918203 - 60 ACTUAT fluticasone propionate 0.232 MG/ACTUAT / salmeterol 0.014 MG/ACTUAT Dry Powder Inhaler

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Fluticasone and Salmeterol Oral Inhalation


The combination of fluticasone and salmeterol (Advair Diskus, Advair HFA, AirDuo Respiclick) is used to treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by asthma. The combination of fluticasone and salmeterol (Advair Diskus) is also used to prevent and treat wheezing, shortness of breath, coughing, and chest tightness caused by chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema). The combination of fluticasone and salmeterol (Advair Diskus) is used in adults and children 4 years of age and older. The combination of fluticasone and salmeterol (Advair HFA, AirDuo Respiclick) is used in children 12 years of age and older. Fluticasone is in a class of medications called steroids. It works by reducing swelling in the airways. Salmeterol is in a class of medications called long-acting beta-agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.
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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
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".