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NDC 66993-136 Fluticasone Furoate And Vilanterol

Powder Respiratory (inhalation) - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 66993-136?
  4. Fluticasone Furoate And Vilanterol 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

NDC Product Code:
66993-136
Proprietary Name:
Fluticasone Furoate And Vilanterol
Non-Proprietary Name: [1]
Fluticasone Furoate And Vilanterol
Substance Name: [2]
Fluticasone Furoate; Vilanterol Trifenatate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Administration Route(s): [4]
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
    • Labeler Name: [5]
    Prasco Laboratories
    Labeler Code:
    66993
    Product Label ID:
    3a761487-c300-451a-8537-3196c00c11b5
    FDA Application Number: [6]
    NDA204275
    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),.
    Start Marketing Date: [9]
    05-23-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 66993-136-97

    Package Description: 1 TRAY in 1 CARTON / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER

    Price per Unit: $3.88185 per EA

    Product Details

    What is NDC 66993-136?

    The NDC code 66993-136 is assigned by the FDA to the product Fluticasone Furoate And Vilanterol which is a human prescription drug product labeled by Prasco Laboratories. The product's dosage form is powder and is administered via respiratory (inhalation) form. The product is distributed in a single package with assigned NDC code 66993-136-97 1 tray in 1 carton / 1 inhaler in 1 tray / 30 powder in 1 inhaler. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Fluticasone Furoate And Vilanterol?

    The use of Fluticasone Furoate/Vilanterol ELLIPTA is contraindicated in the following conditions:•Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required [see Warnings and Precautions (5.2)].•Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate, vilanterol, or any of the excipients [see Warnings and Precautions (5.11), Description (11)].

    What are Fluticasone Furoate And Vilanterol Active Ingredients?

    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.

    Which are Fluticasone Furoate And Vilanterol UNII Codes?

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

    Which are Fluticasone Furoate And Vilanterol Inactive Ingredients 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 Fluticasone Furoate And Vilanterol?

    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: 1424889 - fluticasone furoate/vilanterol 100/25 MCG/INHAL Dry Powder Inhaler, 30 Blisters
    • RxCUI: 1424889 - 30 ACTUAT fluticasone furoate 0.1 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler
    • RxCUI: 1648788 - fluticasone furoate/vilanterol 200/25 MCG/INHAL Dry Powder Inhaler, 30 Blisters
    • RxCUI: 1648788 - 30 ACTUAT fluticasone furoate 0.2 MG/ACTUAT / vilanterol 0.025 MG/ACTUAT Dry Powder Inhaler
    • RxCUI: 1648788 - fluticasone furoate 200 MCG/ACTUAT / vilanterol 25 MCG/ACTUAT (as vilanterol trifenatate 40 MCG/ACTUAT) Dry Powder Inhaler, 30 ACTUAT

    Which are the Pharmacologic Classes for Fluticasone Furoate And Vilanterol?

    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.

    * Please review the disclaimer below.

    Patient Education

    Fluticasone and Vilanterol Oral Inhalation


    The combination of fluticasone and vilanterol is used to control wheezing, shortness of breath, coughing, and chest tightness caused by asthma and chronic obstructive pulmonary (COPD; a group of diseases that affect the lungs and airways, that includes chronic bronchitis and emphysema). Fluticasone is in a class of medications called steroids. It works by reducing swelling in the airways. Vilanterol 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.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".