Ayvakit Tablet, Film Coated
NDC 72064-125
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Ayvakit (avapritinib) is a NDA-approved product labeled by Blueprint Medicines Corporation. This medication is typically used as a bile salt export pump inhibitors [moa]. It is supplied as a tablet, film coated for oral administration. This product entry covers the primary NDC 72064-125 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
72064-125
Proprietary Name:
Ayvakit
Non-Proprietary Name: [1]
Avapritinib
Substance Name: [2]
Avapritinib
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
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 & Regulatory Data
Labeler Name: [5]
Labeler Code:
72064
Product Label ID:
FDA Application Number: [6]
NDA212608
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
06-16-2021
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 72064-125?
The NDC code 72064-125 is assigned by the FDA to the product Ayvakit. It is commonly known by its generic name, avapritinib. This pharmaceutical product is labeled by Blueprint Medicines Corporation and is currently categorized as listed product. The medication is a tablet, film coated administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 72064-125-30. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
None.
What are Active Ingredients of this product?
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.
- AVAPRITINIB 25 mg/1 - A tyrosine kinase receptor inhibitor that targets mutants of PROTO-ONCOGENE PROTEIN KIT and PLATELET-DERIVED GROWTH FACTOR ALPHA RECEPTOR.
Which are the Pharmacologic Classes of this product?
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.
- Bile Salt Export Pump Inhibitors - [MoA] (Mechanism of Action)
- Breast Cancer Resistance Protein Inhibitors - [MoA] (Mechanism of Action)
- Cytochrome P450 2C9 Inhibitors - [MoA] (Mechanism of Action)
- Kinase Inhibitor - [EPC] (Established Pharmacologic Class)
- Multidrug and Toxin Extrusion Transporter 1 Inhibitors - [MoA] (Mechanism of Action)
- Multidrug and Toxin Extrusion Transporter 2 K Inhibitors - [MoA] (Mechanism of Action)
- P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
- Tyrosine Kinase Inhibitors - [MoA] (Mechanism of Action)
* Please review the full disclaimer at the bottom of this page.
Patient Education
Avapritinib
Avapritinib is used to treat a certain type of gastrointestinal stromal tumor (GIST; a type of tumor that grows in the wall of the stomach, intestine [bowel], or esophagus [tube that connects the throat with the stomach]) in adults that has spread to other parts of the body or that cannot be removed by surgery. It is also used to treat certain types of mastocytosis (a blood disorder in which there are too many mast cells [a certain kind of white blood cell]). Avapritinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells.
[Learn More]
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
