Abiraterone Acetate
NDC Package 57894-155-12

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Abiraterone Acetate is a medication used to treat prostate cancer. Marketed by Janssen Biotech, Inc., this product is identified by NDC 57894-155 and is authorized under FDA application NDA202379.

Identification & Billing

NDC Package Code
57894-155-12
Package Description
120 TABLET in 1 BOTTLE
Product Code
57894-155
11-Digit Billing Format
57894015512
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
120 EA

Clinical Specifications

Proprietary Name
Abiraterone Acetate
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
Janssen Biotech, Inc.
FDA Application #
NDA202379
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
02-09-2018
End Marketing Date
01-31-2022
Listing Expiration
01-31-2022
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 57894-155-12 identifies a specific commercial package of 120 tablet in 1 bottle of Abiraterone Acetate, labeled by Janssen Biotech, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Janssen Biotech, Inc. on February 09, 2018. The current certification is valid through January 31, 2022.

What are the primary indications for this medication?

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.

How is this Janssen Biotech, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57894015512. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 120 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
57894-155-12
11-Digit CMS (5-4-2)
57894-0155-12

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.