Gynazole 1
NDC Package 64011-246-01

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.

Gynazole 1 is a medication used to treat vaginal yeast infections. Marketed by Amag Pharmaceuticals, Inc., this product is identified by NDC 64011-246 and is authorized under FDA application ANDA200923.

Identification & Billing

NDC Package Code
64011-246-01
Package Description
1 TUBE in 1 CARTON / 5.8 g in 1 TUBE
Product Code
64011-246
11-Digit Billing Format
64011024601
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
5.8 GM

Clinical Specifications

Proprietary Name
Gynazole 1
Dosage Form
-
Usage Information
This medication is used to treat vaginal yeast infections. Butoconazole reduces vaginal burning, itching, and discharge that may occur with this condition. This medication is an azole antifungal. It works by stopping the growth of yeast (fungus) that causes the infection.

Regulatory & Marketing

Labeler Name
Amag Pharmaceuticals, Inc.
FDA Application #
ANDA200923
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-27-2012
End Marketing Date
10-01-2016
Listing Expiration
10-01-2016
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 64011-246-01 identifies a specific commercial package of 1 tube in 1 carton / 5.8 g in 1 tube of Gynazole 1, labeled by Amag 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 Amag Pharmaceuticals, Inc. on December 27, 2012. The current certification is valid through October 01, 2016.

What are the primary indications for this medication?

This medication is used to treat vaginal yeast infections. Butoconazole reduces vaginal burning, itching, and discharge that may occur with this condition. This medication is an azole antifungal. It works by stopping the growth of yeast (fungus) that causes the infection.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64011024601. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 5.8 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)
64011-246-01
11-Digit CMS (5-4-2)
64011-0246-01

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