Terconazole
NDC Package 54868-5183-0

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 inactivated by the FDA.

Terconazole is a medication used to treat vaginal yeast infections. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5183 and is authorized under FDA application ANDA075953.

Identification & Billing

NDC Package Code
54868-5183-0
Package Description
1 TUBE, WITH APPLICATOR in 1 CARTON / 20 g in 1 TUBE, WITH APPLICATOR
Product Code
54868-5183
11-Digit Billing Format
54868518300
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
20 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Terconazole
Dosage Form
-
Usage Information
This medication is used to treat vaginal yeast infections. Terconazole 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
Physicians Total Care, Inc.
FDA Application #
ANDA075953
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-18-2004
Listing Expiration
12-31-2017
Exclude Flag
I
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 54868-5183-0 identifies a specific commercial package of 1 tube, with applicator in 1 carton / 20 g in 1 tube, with applicator of Terconazole, labeled by Physicians Total Care, Inc.. This product is billed per "GM" gram and contains an estimated amount of 20 billable units per package. 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 November 18, 2004. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This medication is used to treat vaginal yeast infections. Terconazole 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 Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868518300. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 20 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 (5-4-1)
54868-5183-0
11-Digit CMS (5-4-2)
54868-5183-00

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