Flutamide
NDC Package 54868-4628-0

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.

Flutamide is a medication used to treat men with prostate cancer. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4628 and is authorized under FDA application ANDA075820.

Identification & Billing

NDC Package Code
54868-4628-0
Package Description
180 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
54868-4628
11-Digit Billing Format
54868462800

Clinical Specifications

Proprietary Name
Flutamide
Dosage Form
-
Usage Information
This medication is used to treat men with prostate cancer. Flutamide belongs to a class of drugs known as anti-androgens (anti-testosterone). Testosterone, a natural hormone, helps prostate cancer to grow and spread. Flutamide works by blocking the effects of testosterone, thereby slowing the growth and spread of prostate cancer.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA075820
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-18-2001
End Marketing Date
06-30-2004
Listing Expiration
06-30-2004
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 54868-4628-0 identifies a specific commercial package of 180 capsule in 1 bottle, plastic of Flutamide, labeled by Physicians Total Care, 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 Physicians Total Care, Inc. on September 18, 2001. The current certification is valid through June 30, 2004.

What are the primary indications for this medication?

This medication is used to treat men with prostate cancer. Flutamide belongs to a class of drugs known as anti-androgens (anti-testosterone). Testosterone, a natural hormone, helps prostate cancer to grow and spread. Flutamide works by blocking the effects of testosterone, thereby slowing the growth and spread of prostate cancer.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868462800. 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 (5-4-1)
54868-4628-0
11-Digit CMS (5-4-2)
54868-4628-00

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