Vitrakvi Solution, Concentrate
NDC Package 50419-392-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Vitrakvi (larotrectinib) solution is larotrectinib is used to treat cancer. This formulation utilizes a solution, concentrate delivery system. Marketed by Bayer Healthcare Pharmaceuticals Inc., this product is identified by NDC 50419-392 and is authorized under FDA application NDA211710.

Identification & Billing

NDC Package Code
50419-392-01
Package Description
100 mL in 1 BOTTLE
Product Code
50419-392
11-Digit Billing Format
50419039201
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
100 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vitrakvi
Non-Proprietary Name
Larotrectinib
Substance Name
Larotrectinib
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
Oropharyngeal - Administration directly to the mouth and pharynx.
Active Ingredient(s)
LAROTRECTINIB 20 mg/mL
Pharmacologic Class
Usage Information
Larotrectinib is used to treat cancer. It works by slowing or stopping the growth of cancer cells.

Regulatory & Marketing

Labeler Name
Bayer Healthcare Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA211710
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-26-2019
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50419-392-01 identifies a specific commercial package of 100 ml in 1 bottle of Vitrakvi, a human prescription drug labeled by Bayer Healthcare Pharmaceuticals Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 100 billable units per package. This solution, concentrate is formulated for oropharyngeal use and contains larotrectinib as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Bayer Healthcare Pharmaceuticals Inc. on July 26, 2019. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Larotrectinib is used to treat cancer. It works by slowing or stopping the growth of cancer cells.

How is this Bayer Healthcare Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50419039201. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 100 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
50419-392-01
11-Digit CMS (5-4-2)
50419-0392-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.