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  5. NDC Package Code: 59676-600-12 Erleada

NDC Package 59676-600-12 Erleada

Apalutamide 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:
59676-600-12
Package Description:
120 TABLET, FILM COATED in 1 BOTTLE
Product Code:
59676-600
Proprietary Name:
Erleada
Non-Proprietary Name:
Apalutamide
Substance Name:
Apalutamide
Usage Information:
Apalutamide is used to treat men with prostate cancer. This medication belongs to a class of drugs known as anti-androgens (anti-testosterone). It works by blocking the effects of testosterone to slow the growth and spread of prostate cancer.
11-Digit NDC Billing Format:
59676060012
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
120 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1999581 - apalutamide 60 MG Oral Tablet
  • RxCUI: 1999587 - Erleada 60 MG Oral Tablet
  • RxCUI: 1999587 - apalutamide 60 MG Oral Tablet [Erleada]
  • RxCUI: 2630215 - apalutamide 240 MG Oral Tablet
  • RxCUI: 2630217 - Erleada 240 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Janssen Products, Lp
    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):
  • APALUTAMIDE 60 mg/1
    • Sample Package:
    No
    FDA Application Number:
    NDA210951
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    02-14-2018
    Listing Expiration Date:
    12-31-2025
    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
    59676-600-562 BLISTER PACK in 1 CARTON / 28 TABLET, FILM COATED in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 59676-600-12?

    The NDC Packaged Code 59676-600-12 is assigned to a package of 120 tablet, film coated in 1 bottle of Erleada, a human prescription drug labeled by Janssen Products, Lp. The product's dosage form is tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 120 billable units per package.

    Is NDC 59676-600 included in the NDC Directory?

    Yes, Erleada with product code 59676-600 is active and included in the NDC Directory. The product was first marketed by Janssen Products, Lp on February 14, 2018 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 59676-600-12?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 120.

    What is the 11-digit format for NDC 59676-600-12?

    The 11-digit format is 59676060012. 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
    5-3-259676-600-125-4-259676-0600-12