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  5. NDC Package Code: 57894-195-15 Zytiga

NDC Package 57894-195-15 Zytiga

Abiraterone Acetate 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:
57894-195-15
Package Description:
60 TABLET, FILM COATED in 1 BOTTLE
Product Code:
57894-195
Proprietary Name:
Zytiga
Non-Proprietary Name:
Abiraterone Acetate
Substance Name:
Abiraterone Acetate
Usage Information:
This medication is used to treat prostate cancer. Abiraterone belongs to a class of drugs known as anti-androgens (anti-testosterone). Testosterone, a natural hormone, helps prostate cancer to grow and spread. Abiraterone works by blocking the production of testosterone, thereby slowing the growth and spread of prostate cancer. This medication should not be given to women or children.
11-Digit NDC Billing Format:
57894019515
NDC to RxNorm Crosswalk:
  • RxCUI: 1100075 - abiraterone acetate 250 MG Oral Tablet
  • RxCUI: 1100079 - Zytiga 250 MG Oral Tablet
  • RxCUI: 1100079 - abiraterone acetate 250 MG Oral Tablet [Zytiga]
  • RxCUI: 1918042 - abiraterone acetate 500 MG Oral Tablet
  • RxCUI: 1918044 - Zytiga 500 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Janssen Biotech, 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):
  • ABIRATERONE ACETATE 500 mg/1
    • Pharmacologic Class(es):
  • Cytochrome P450 17A1 Inhibitor - [EPC] (Established Pharmacologic Class)
  • Cytochrome P450 17A1 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C8 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 2D6 Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    Yes
    FDA Application Number:
    NDA202379
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    04-17-2017
    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
    57894-195-0660 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 57894-195-15?

    The NDC Packaged Code 57894-195-15 is assigned to a package of 60 tablet, film coated in 1 bottle of Zytiga, a human prescription drug labeled by Janssen Biotech, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 57894-195 included in the NDC Directory?

    Yes, Zytiga with product code 57894-195 is active and included in the NDC Directory. The product was first marketed by Janssen Biotech, Inc. on April 17, 2017 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 57894-195-15?

    The 11-digit format is 57894019515. 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
    5-3-257894-195-155-4-257894-0195-15