NDC 70709-065 Tascenso Odt

Fingolimod Lauryl Sulfate Tablet, Orally Disintegrating Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
70709-065
Proprietary Name:
Tascenso Odt
Non-Proprietary Name: [1]
Fingolimod Lauryl Sulfate
Substance Name: [2]
Fingolimod Lauryl Sulfate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Cycle Pharmaceuticals Ltd
    Labeler Code:
    70709
    FDA Application Number: [6]
    NDA214962
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    02-01-2023
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 70709-065-30

    Package Description: 3 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

    Product Details

    What is NDC 70709-065?

    The NDC code 70709-065 is assigned by the FDA to the product Tascenso Odt which is a human prescription drug product labeled by Cycle Pharmaceuticals Ltd. The generic name of Tascenso Odt is fingolimod lauryl sulfate. The product's dosage form is tablet, orally disintegrating and is administered via oral form. The product is distributed in a single package with assigned NDC code 70709-065-30 3 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack. 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 Tascenso Odt?

    TASCENSO ODT is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in pediatric patients 10 years of age and older and weighing less than or equal to 40 kg.

    What are Tascenso Odt 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.

    What is the NDC to RxNorm Crosswalk for Tascenso Odt?

    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: 2610295 - fingolimod 0.25 MG Disintegrating Oral Tablet
    • RxCUI: 2610295 - fingolimod 0.25 MG (as fingolimod lauryl sulfate 0.47 MG) Disintegrating Oral Tablet
    • RxCUI: 2610302 - Tascenso ODT 0.25 MG Disintegrating Oral Tablet
    • RxCUI: 2610302 - fingolimod 0.25 MG Disintegrating Oral Tablet [Tascenso]
    • RxCUI: 2610302 - Tascenso 0.25 MG (as fingolimod lauryl sulfate 0.47 MG) Disintegrating Oral Tablet

    Which are the Pharmacologic Classes for Tascenso Odt?

    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

    Fingolimod


    Fingolimod is used to prevent episodes of symptoms and slow the worsening of disability in adults and children 10 years of age and older with relapsing-remitting forms (course of disease where symptoms flare up from time to time) of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control). Fingolimod is in a class of medications called sphingosine l-phosphate receptor modulators. It works by decreasing the action of immune cells that may cause nerve damage.
    [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".