Vitrakvi Solution, Concentrate
NDC 50419-392

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 50419-392?
  5. Vitrakvi Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Vitrakvi (larotrectinib) is a NDA-approved product labeled by Bayer Healthcare Pharmaceuticals Inc.. Larotrectinib is used to treat cancer. It is supplied as a white solution, concentrate for oropharyngeal administration. This product entry covers the primary NDC 50419-392 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
50419-392
Proprietary Name:
Vitrakvi
Non-Proprietary Name: [1]
Larotrectinib
Substance Name: [2]
Larotrectinib
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Solution, Concentrate - A liquid preparation (i.e., a substance that flows readily in its natural state) that contains a drug dissolved in a suitable solvent or mixture of mutually miscible solvents; the drug has been strengthened by the evaporation of its nonactive parts.
Administration Route(s): [4]
Oropharyngeal - Administration directly to the mouth and pharynx.

Labeler & Regulatory Data

Labeler Name: [5]
Bayer Healthcare Pharmaceuticals Inc.
Labeler Code:
50419
Product Label ID:
0c8ca614-58b2-4aa4-83d3-0387a8f782fd
FDA Application Number: [6]
NDA211710
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
07-26-2019
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325 - OPAQUE WHITE)
YELLOW (C48330 - CLEAR YELLOW TO ORANGE)
Shape:
CAPSULE (C48336)
Size(s):
18 MM
22 MM
Imprint(s):
BAYER;25MG
BAYER;100MG
Score:
1
Flavor(s):

Code Structure Chart

Product Details

What is NDC 50419-392?

The NDC code 50419-392 is assigned by the FDA to the product Vitrakvi. It is commonly known by its generic name, larotrectinib. This pharmaceutical product is labeled by Bayer Healthcare Pharmaceuticals Inc. and is currently categorized as listed product. The medication is a solution, concentrate administered via oropharyngeal route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 50419-392-01. 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?

Larotrectinib is used to treat cancer. It works by slowing or stopping the growth of cancer cells. VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that:•have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,•are metastatic or where surgical resection is likely to result in severe morbidity, and•have no satisfactory alternative treatments or that have progressed following treatment.This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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 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.

* Please review the full disclaimer at the bottom of this page.

Patient Education

Larotrectinib


Larotrectinib is used to treat a certain type of solid tumors in adults, children, and infants 4 weeks of age and older that have spread to other parts of the body or cannot be treated successfully with surgery. This medication is used only if there are no other treatments available and the tumors have worsened after receiving other treatments. Larotrectinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that tells the cancer cells to multiply. This may help slow the growth of tumors.
[Learn More]


Cancer Chemotherapy


What is cancer chemotherapy?

Cancer chemotherapy is a type of cancer treatment. It uses medicines to destroy cancer cells.

Normally, the cells in your body grow and die in a controlled way. Cancer cells keep growing without control. Chemotherapy works by killing the cancer cells, stopping them from spreading, or slowing their growth.

Chemotherapy is used to:

  • Treat cancer by curing the cancer, lessening the chance it will return, or stopping or slowing its growth.
  • Ease cancer symptoms by shrinking tumors that are causing pain and other problems.

What are the side effects of chemotherapy?

Chemotherapy does not just destroy cancer cells. It can also harm some healthy cells, which causes side effects.

You may have a lot of side effects, some side effects, or none at all. It depends on the type and amount of chemotherapy you get and how your body reacts.

Some common side effects are:

There are ways to prevent or control some side effects. Talk with your health care provider about how to manage them. Healthy cells usually recover after chemotherapy is over, so most side effects gradually go away.

What can I expect when getting chemotherapy?

You may get chemotherapy in a hospital or at home, a doctor's office, or a medical clinic. You might be given the medicines by mouth, in a shot, as a cream, through a catheter, or intravenously (by IV).

Your treatment plan will depend on the type of cancer you have, which chemotherapy medicines are used, the treatment goals, and how your body responds to the medicines.

Chemotherapy may be given alone or with other treatments. You may get treatment every day, every week, or every month. You may have breaks between treatments so that your body has a chance to build new healthy cells.

NIH: National Cancer Institute


[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".