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  5. NDC Package Code: 43598-458-36 Sorafenib

NDC Package 43598-458-36 Sorafenib

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
43598-458-36
Package Description:
360 TABLET, FILM COATED in 1 BOTTLE
Product Code:
43598-458
Proprietary Name:
Sorafenib
Non-Proprietary Name:
Sorafenib
Substance Name:
Sorafenib Tosylate
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:
43598045836
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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Dr.reddys Laboratories 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 TOSYLATE 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:
    ANDA216073
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-08-2022
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    43598-458-04120 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 43598-458-36?

    The NDC Packaged Code 43598-458-36 is assigned to a package of 360 tablet, film coated in 1 bottle of Sorafenib, a human prescription drug labeled by Dr.reddys Laboratories Inc. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 43598-458 included in the NDC Directory?

    Yes, Sorafenib with product code 43598-458 is active and included in the NDC Directory. The product was first marketed by Dr.reddys Laboratories Inc on June 08, 2022 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 43598-458-36?

    The 11-digit format is 43598045836. 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
    5-3-243598-458-365-4-243598-0458-36