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  4. NDC Product Code: 65597-203 Savaysa

NDC 65597-203 Savaysa

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

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 65597-203?
  5. Savaysa Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

NDC Product Code:
65597-203
Proprietary Name:
Savaysa
Non-Proprietary Name: [1]
Edoxaban Tosylate
Substance Name: [2]
Edoxaban Tosylate
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]
    Daiichi Sankyo Inc.
    Labeler Code:
    65597
    Product Label ID:
    e77d3400-56ad-11e3-949a-0800200c9a66
    FDA Application Number: [6]
    NDA206316
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    01-12-2015
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    ORANGE (C48331)
    PINK (C48328)
    YELLOW (C48330)
    Shape:
    ROUND (C48348)
    Size(s):
    7 MM
    9 MM
    11 MM
    Imprint(s):
    DSC;L15
    DSC;L30
    DSC;L60
    Score:
    1

    Product Packages

    NDC Code 65597-203-05

    Package Description: 50 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK

    Price per Unit: $12.46092 per EA

    NDC Code 65597-203-07

    Package Description: 7 TABLET, FILM COATED in 1 BOTTLE

    NDC Code 65597-203-10

    Package Description: 100 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK

    NDC Code 65597-203-30

    Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

    Price per Unit: $13.21032 per EA

    NDC Code 65597-203-50

    Package Description: 500 TABLET, FILM COATED in 1 BOTTLE

    NDC Code 65597-203-70

    Package Description: 7 TABLET, FILM COATED in 1 BLISTER PACK

    NDC Code 65597-203-90

    Package Description: 90 TABLET, FILM COATED in 1 BOTTLE

    Price per Unit: $12.46092 per EA

    Product Details

    What is NDC 65597-203?

    The NDC code 65597-203 is assigned by the FDA to the product Savaysa which is a human prescription drug product labeled by Daiichi Sankyo Inc.. The generic name of Savaysa is edoxaban tosylate. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 7 packages with assigned NDC codes 65597-203-05 50 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack, 65597-203-07 7 tablet, film coated in 1 bottle , 65597-203-10 100 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack, 65597-203-30 30 tablet, film coated in 1 bottle , 65597-203-50 500 tablet, film coated in 1 bottle , 65597-203-70 7 tablet, film coated in 1 blister pack , 65597-203-90 90 tablet, film coated in 1 bottle . 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 Savaysa?

    Edoxaban is used to prevent serious blood clots from forming due to a certain irregular heartbeat (atrial fibrillation). It is also used to treat certain blood clots (such as in deep vein thrombosis-DVT or pulmonary embolus-PE). Edoxaban is an anticoagulant that works by blocking certain clotting proteins in your blood.

    What are Savaysa 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 Savaysa UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Savaysa?

    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 Savaysa?

    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

    Edoxaban


    Edoxaban is used help prevent strokes or blood clots in people who have atrial fibrillation (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body and possibly causing strokes) that is not caused by heart valve disease. Edoxaban is also used to prevent deep vein thrombosis (DVT; a blood clot, usually in the leg) and pulmonary embolism (PE; a blood clot in the lung) in people who have been treated with an injectable blood thinner medicine for 5 to 10 days. Edoxaban is in a class of medications called factor Xa inhibitors. It works by blocking the action of a certain natural substance that helps blood clots to form.
    [Learn More]


    Blood Thinners


    What are blood thinners?

    Blood thinners are medicines that prevent blood clots from forming. They do not break up clots that you already have. But they can stop those clots from getting bigger. It's important to treat blood clots, because clots in your blood vessels and heart can cause heart attacks, strokes, and blockages.

    Who needs blood thinners?

    You may need a blood thinner if you have:

    What are the different types of blood thinners?

    There are different types of blood thinners:

    • Anticoagulants, such as heparin or warfarin (also called Coumadin), slow down your body's process of making clots.
    • Antiplatelets, such as aspirin and clopidogrel, prevent blood cells called platelets from clumping together to form a clot. Antiplatelets are mainly taken by people who have had a heart attack or stroke.

    How can I take blood thinners safely?

    When you take a blood thinner, follow the directions carefully. Blood thinners may interact with certain foods, medicines, vitamins, and alcohol. Make sure that your health care provider knows all of the medicines and supplements you are using.

    You may need regular blood tests to check how well your blood is clotting. It is important to make sure that you're taking enough medicine to prevent clots, but not so much that it causes bleeding.

    What are the side effects of blood thinners?

    Bleeding is the most common side effect of blood thinners. They can also cause an upset stomach, nausea, and diarrhea.

    Other possible side effects can depend on which type of blood thinner that you are taking.

    Call your provider if you have any sign of serious bleeding, such as:

    • Menstrual bleeding that is much heavier than normal
    • Red or brown urine
    • Bowel movements that are red or black
    • Bleeding from the gums or nose that does not stop quickly
    • Vomit that is brown or bright red
    • Coughing up something red
    • Severe pain, such as a headache or stomachache
    • Unusual bruising
    • A cut that does not stop bleeding
    • A serious fall or bump on the head
    • Dizziness or weakness

    [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".