NDC 0078-1028 Vijoice

Alpelisib Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0078-1028
Proprietary Name:
Vijoice
Non-Proprietary Name: [1]
Alpelisib
Substance Name: [2]
Alpelisib
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Code:
    0078
    FDA Application Number: [6]
    NDA215039
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    04-05-2022
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330 - LIGHT)
    YELLOW (C48330 - DARK)
    Shape:
    ROUND (C48348)
    OVAL (C48345)
    Size(s):
    7 MM
    13 MM
    Imprint(s):
    C7;NVR
    Y7;NVR
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 0078-1028?

    The NDC code 0078-1028 is assigned by the FDA to the product Vijoice which is a human prescription drug product labeled by Novartis Pharmaceuticals Corporation. The generic name of Vijoice is alpelisib. The product's dosage form is tablet and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0078-1028-84 1 blister pack in 1 carton / 28 tablet in 1 blister pack (0078-1028-51), 0078-1028-91 1 blister pack in 1 carton / 28 tablet in 1 blister pack (0078-1028-90). 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 Vijoice?

    This medication is used to treat certain types of breast cancer. Alpelisib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells.

    What are Vijoice 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 Vijoice UNII Codes?

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

    Which are Vijoice 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 Vijoice?

    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:

    * Please review the disclaimer below.

    Patient Education

    Alpelisib


    Alpelisib (Piqray) is used in combination with fulvestrant (Faslodex) to treat a certain type of breast cancer that has spread to nearby tissues or other parts of the body in women who have already gone through menopause (''change of life,'' end of menstrual periods) or in men, whose cancer got worse during or after certain other treatments. Alpelisib (Vijoice) is used to treat adults and children 2 years of age or older who have certain types of PIK3CA Related Overgrowth Spectrum (PROS; a genetic condition that causes overgrowth and abnormalities in certain body tissues). Alpelisib is in a class of medications called kinase inhibitors. It works to treat cancer by blocking the signals that cause cancer cells to multiply, which helps to stop the spread of cancer cells. It works to treast PROS by blocking the signals that cause overgrowth and abnormalities in certain body tissues, which reduces the size of the overgrowths and improves symptoms.
    [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".