Anastrozole
NDC Package 63672-0015-0

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.

Anastrozole is used to treat breast cancer in women after menopause. Marketed by Synthon Pharmaceuticals, Inc., this product is identified by NDC 63672-0015 and is authorized under FDA application ANDA078322.

Identification & Billing

NDC Package Code
63672-0015-0
Package Description
50000 TABLET, FILM COATED in 1 DRUM
Product Code
63672-0015
11-Digit Billing Format
63672001500

Clinical Specifications

Proprietary Name
Anastrozole
Dosage Form
-
Usage Information
Anastrozole is used to treat breast cancer in women after menopause. Some breast cancers are made to grow faster by a natural hormone called estrogen. Anastrozole decreases the amount of estrogen the body makes and helps to slow or reverse the growth of these breast cancers.

Regulatory & Marketing

Labeler Name
Synthon Pharmaceuticals, Inc.
FDA Application #
ANDA078322
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-28-2010
End Marketing Date
06-28-2010
Listing Expiration
06-28-2010
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 63672-0015-0 identifies a specific commercial package of 50000 tablet, film coated in 1 drum of Anastrozole, labeled by Synthon Pharmaceuticals, 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 Synthon Pharmaceuticals, Inc. on June 28, 2010. The current certification is valid through June 28, 2010.

What are the primary indications for this medication?

Anastrozole is used to treat breast cancer in women after menopause. Some breast cancers are made to grow faster by a natural hormone called estrogen. Anastrozole decreases the amount of estrogen the body makes and helps to slow or reverse the growth of these breast cancers.

How is this Synthon Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63672001500. 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)
63672-0015-0
11-Digit CMS (5-4-2)
63672-0015-00

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