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  5. NDC Package Code: 50419-489-01 Nexavar

NDC Package 50419-489-01 Nexavar

Sorafenib Tablet, Film Coated Oral - 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:
50419-489-01
Package Description:
120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code:
50419-489
Proprietary Name:
Nexavar
Non-Proprietary Name:
Sorafenib
Substance Name:
Sorafenib
Usage Information:
Sorafenib is used to treat kidney, liver, and thyroid cancer. It works by slowing or stopping the growth of cancer cells.
11-Digit NDC Billing Format:
50419048901
NDC to RxNorm Crosswalk:
  • RxCUI: 597747 - SORAfenib 200 MG Oral Tablet
  • RxCUI: 597747 - sorafenib 200 MG Oral Tablet
  • RxCUI: 597747 - sorafenib (as sorafenib tosylate) 200 MG Oral Tablet
  • RxCUI: 615979 - NexAVAR 200 MG Oral Tablet
  • RxCUI: 615979 - sorafenib 200 MG Oral Tablet [Nexavar]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bayer Healthcare Pharmaceuticals Inc.
    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):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • SORAFENIB 200 mg/1
    • Pharmacologic Class(es):
  • Kinase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Protein Kinase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA021923
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    10-02-2023
    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 50419-489-01?

    The NDC Packaged Code 50419-489-01 is assigned to a package of 120 tablet, film coated in 1 bottle, plastic of Nexavar, a human prescription drug labeled by Bayer Healthcare Pharmaceuticals Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 50419-489 included in the NDC Directory?

    Yes, Nexavar with product code 50419-489 is active and included in the NDC Directory. The product was first marketed by Bayer Healthcare Pharmaceuticals Inc. on October 02, 2023 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 11-digit format for NDC 50419-489-01?

    The 11-digit format is 50419048901. 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
    5-3-250419-489-015-4-250419-0489-01