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  5. NDC Package Code: 50419-392-01 Vitrakvi

NDC Package 50419-392-01 Vitrakvi

Larotrectinib Solution, Concentrate Oropharyngeal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
50419-392-01
Package Description:
100 mL in 1 BOTTLE
Product Code:
50419-392
Proprietary Name:
Vitrakvi
Non-Proprietary Name:
Larotrectinib
Substance Name:
Larotrectinib
Usage Information:
Larotrectinib is used to treat cancer. It works by slowing or stopping the growth of cancer cells.
11-Digit NDC Billing Format:
50419039201
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
100 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 2105633 - larotrectinib 100 MG Oral Capsule
  • RxCUI: 2105633 - larotrectinib 100 MG (as 123 MG larotrectinib sulfate) oral capsule
  • RxCUI: 2105645 - VITRAKVI 100 MG Oral Capsule
  • RxCUI: 2105645 - larotrectinib 100 MG Oral Capsule [Vitrakvi]
  • RxCUI: 2105645 - Vitrakvi 100 MG (as 123 MG larotrectinib sulfate) Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bayer Healthcare Pharmaceuticals Inc.
    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):
  • Oropharyngeal - Administration directly to the mouth and pharynx.
    • Active Ingredient(s):
  • LAROTRECTINIB 20 mg/mL
    • Pharmacologic Class(es):
  • Kinase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Tropomyosin Receptor Kinases Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA211710
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    07-26-2019
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 50419-392-01?

    The NDC Packaged Code 50419-392-01 is assigned to a package of 100 ml in 1 bottle of Vitrakvi, a human prescription drug labeled by Bayer Healthcare Pharmaceuticals Inc.. The product's dosage form is solution, concentrate and is administered via oropharyngeal form.This product is billed per "ML" milliliter and contains an estimated amount of 100 billable units per package.

    Is NDC 50419-392 included in the NDC Directory?

    Yes, Vitrakvi with product code 50419-392 is active and included in the NDC Directory. The product was first marketed by Bayer Healthcare Pharmaceuticals Inc. on July 26, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 50419-392-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 50419-392-01?

    The 11-digit format is 50419039201. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-250419-392-015-4-250419-0392-01