NDC 50419-252 Adempas

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

Product Information

NDC Product Code:
50419-252
Proprietary Name:
Adempas
Non-Proprietary Name: [1]
Riociguat
Substance Name: [2]
Riociguat
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]
    Bayer Healthcare Pharmaceuticals Inc.
    Labeler Code:
    50419
    FDA Application Number: [6]
    NDA204819
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    10-08-2013
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)
    YELLOW (C48330 - PALE)
    YELLOW (C48330 - ORANGE)
    Shape:
    ROUND (C48348)
    Size(s):
    6 MM
    Imprint(s):
    5R;BAYER
    1R;BAYER
    15R;BAYER
    Score:
    1

    Product Packages

    NDC Code 50419-252-01

    Package Description: 90 TABLET, FILM COATED in 1 BOTTLE

    NDC Code 50419-252-03

    Package Description: 2 BLISTER PACK in 1 PACKAGE / 21 TABLET, FILM COATED in 1 BLISTER PACK

    NDC Code 50419-252-91

    Package Description: 9 TABLET, FILM COATED in 1 BOTTLE

    Product Details

    What is NDC 50419-252?

    The NDC code 50419-252 is assigned by the FDA to the product Adempas which is a human prescription drug product labeled by Bayer Healthcare Pharmaceuticals Inc.. The generic name of Adempas is riociguat. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 50419-252-01 90 tablet, film coated in 1 bottle , 50419-252-03 2 blister pack in 1 package / 21 tablet, film coated in 1 blister pack, 50419-252-91 9 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 Adempas?

    Riociguat is used to treat high blood pressure in the lungs (pulmonary hypertension). It can also be used to treat a certain type of high blood pressure in the lungs caused by blood clots (chronic thromboembolic pulmonary hypertension) when surgery has not been fully successful or is impossible. Riociguat works by relaxing and widening the blood vessels in your lungs so blood can flow more easily. Decreasing high blood pressure in the lungs allows your heart and lungs to work better and improves your ability to exercise.

    What are Adempas 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 Adempas UNII Codes?

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

    Which are Adempas 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 Adempas?

    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 Adempas?

    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

    Riociguat


    Riociguat is used to treat pulmonary arterial hypertension (PAH; high blood pressure in the vessels that carry blood to the lungs). Riociguat is also used to treat chronic thromboembolic pulmonary hypertension (CTEPH; high blood pressure in the lung arteries caused by blood clots that narrow or block blood flow) in adults who cannot have surgery or for those treated with surgery who continue to have high lung blood pressure levels after surgery. Riociguat may improve the ability to exercise in people with PAH and CTEPH and may slow the worsening of symptoms in people with PAH. Riociguat is in a class of medications called soluble guanylate cyclase (sGC) stimulators. It works by relaxing the blood vessels in the lungs to allow blood to flow easily.
    [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".