NDC 61958-0801 Letairis

Ambrisentan Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
61958-0801
Proprietary Name:
Letairis
Non-Proprietary Name: [1]
Ambrisentan
Substance Name: [2]
Ambrisentan
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Gilead Sciences, Inc
    Labeler Code:
    61958
    FDA Application Number: [6]
    NDA022081
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    06-15-2007
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    PINK (C48328)
    Shape:
    SQUARE (C48350)
    Size(s):
    7 MM
    Imprint(s):
    GSI;5
    Score:
    1

    Product Packages

    NDC Code 61958-0801-1

    Package Description: 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

    NDC Code 61958-0801-2

    Package Description: 3 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK

    NDC Code 61958-0801-3

    Package Description: 1 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK

    NDC Code 61958-0801-4

    Package Description: 1 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK

    NDC Code 61958-0801-5

    Package Description: 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

    NDC Code 61958-0801-6

    Package Description: 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

    Product Details

    What is NDC 61958-0801?

    The NDC code 61958-0801 is assigned by the FDA to the product Letairis which is a human prescription drug product labeled by Gilead Sciences, Inc. The generic name of Letairis is ambrisentan. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 6 packages with assigned NDC codes 61958-0801-1 30 tablet, film coated in 1 bottle, plastic , 61958-0801-2 3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack, 61958-0801-3 1 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack, 61958-0801-4 1 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack, 61958-0801-5 10 tablet, film coated in 1 bottle, plastic , 61958-0801-6 10 tablet, film coated in 1 bottle, plastic . 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 Letairis?

    Ambrisentan is used to treat high blood pressure in the lungs (pulmonary arterial hypertension). This condition is thought to be caused by increased levels of a certain natural substance (endothelin-1). This medication blocks the effects of endothelin-1, thereby helping to decrease the blood pressure in the lungs, slow the worsening of symptoms, and improve your ability to exercise.

    What are Letairis 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 Letairis UNII Codes?

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

    Which are Letairis 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 Letairis?

    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:

    Which are the Pharmacologic Classes for Letairis?

    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

    Ambrisentan


    Ambrisentan is used alone or in combination with tadalafil (Adcirca, Cialis) to treat pulmonary arterial hypertension (PAH, high blood pressure in the vessels that carry blood to the lungs). Ambrisentan may improve the ability to exercise and slow the worsening of symptoms in people with PAH. Ambrisentan is in a class of medications called endothelin receptor antagonists. It works by stopping the action of endothelin, a natural substance that causes blood vessels to narrow and prevents normal blood flow in people who have PAH.
    [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".