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  2. Merck Sharp & Dohme Llc
  3. NDC Product Code: 0006-5331 Welireg

NDC 0006-5331 Welireg

Belzutifan 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 0006-5331?
    5. Welireg Uses
    6. Active Ingredients
    7. Active Ingredients UNII Codes
    8. Inactive Ingredients UNII Codes
    9. Pharmacologic Classes
    10. Patient Education

Product Information

NDC Product Code:
0006-5331
Proprietary Name:
Welireg
Non-Proprietary Name: [1]
Belzutifan
Substance Name: [2]
Belzutifan
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]
    Merck Sharp & Dohme Llc
    Labeler Code:
    0006
    Product Label ID:
    13e15ee0-d679-4fa9-9430-e2e2170474da
    FDA Application Number: [6]
    NDA215383
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    08-13-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    BLUE (C48333)
    Shape:
    OVAL (C48345)
    Size(s):
    13 MM
    Imprint(s):
    177
    Score:
    1

    Product Packages

    NDC Code 0006-5331-01

    Package Description: 90 TABLET, FILM COATED in 1 BOTTLE

    NDC Code 0006-5331-58

    Package Description: 1 BOTTLE in 1 CARTON / 90 TABLET, FILM COATED in 1 BOTTLE

    NDC Code 0006-5331-59

    Package Description: 1 BOTTLE in 1 CARTON / 90 TABLET, FILM COATED in 1 BOTTLE

    Product Details

    What is NDC 0006-5331?

    The NDC code 0006-5331 is assigned by the FDA to the product Welireg which is a human prescription drug product labeled by Merck Sharp & Dohme Llc. The generic name of Welireg is belzutifan. 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 0006-5331-01 90 tablet, film coated in 1 bottle , 0006-5331-58 1 bottle in 1 carton / 90 tablet, film coated in 1 bottle, 0006-5331-59 1 bottle in 1 carton / 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 Welireg?

    WELIREG is indicated for treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.

    What are Welireg 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 Welireg UNII Codes?

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

    Which are Welireg 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:

    Which are the Pharmacologic Classes for Welireg?

    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

    Belzutifan


    Belzutifan is used in adults with von Hippel-Lindau disease (VHL; a rare disease that causes tumors and cysts) to treat renal cell carcinoma (RCC; kidney cancer), central nervous system (CNS) hemangioblastomas (tumors in the brain and spinal cord), and a certain type of pancreatic cancer that does not require surgery right away. Belzutifan is in a class of medications called hypoxia-inducible factor inhibitors. It works by blocking the activity of a certain protein in people with VHL.
    [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".