Bicalutamide
NDC Package 41616-485-08

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

Package Information

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

Bicalutamide is used to treat prostate cancer. Marketed by Sun Pharma Global Inc., this product is identified by NDC 41616-485 and is authorized under FDA application ANDA079110.

Identification & Billing

NDC Package Code
41616-485-08
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
41616-485
11-Digit Billing Format
41616048508

Clinical Specifications

Proprietary Name
Bicalutamide
Dosage Form
-
Usage Information
Bicalutamide is used to treat prostate cancer. This medication works by blocking the action of male hormones in the prostate, slowing the growth of cancer cells. This medication should not be used in women and children.

Regulatory & Marketing

Labeler Name
Sun Pharma Global Inc.
FDA Application #
ANDA079110
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-07-2009
End Marketing Date
07-31-2017
Listing Expiration
07-31-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (41616-485). Click a package code to view its specific billing and regulatory data.

41616-485-18
1000 TABLET, FILM COATED in 1 BOTTLE
41616-485-83
30 TABLET, FILM COATED in 1 BOTTLE
41616-485-88
100 TABLET, FILM COATED in 1 BOTTLE

* 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 41616-485-08 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Bicalutamide, labeled by Sun Pharma Global 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 Sun Pharma Global Inc. on July 07, 2009. The current certification is valid through July 31, 2017.

What are the primary indications for this medication?

Bicalutamide is used to treat prostate cancer. This medication works by blocking the action of male hormones in the prostate, slowing the growth of cancer cells. This medication should not be used in women and children.

How is this Sun Pharma Global Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41616048508. 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)
41616-485-08
11-Digit CMS (5-4-2)
41616-0485-08

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