Terconazole Cream
NDC Package 51672-1302-0

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

Package Information

Terconazole cream is a medication used to treat vaginal yeast infections. This formulation utilizes a cream delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 51672-1302 and is authorized under FDA application ANDA075953.

Identification & Billing

NDC Package Code
51672-1302-0
Package Description
1 TUBE, WITH APPLICATOR in 1 CARTON / 20 g in 1 TUBE, WITH APPLICATOR
Product Code
51672-1302
11-Digit Billing Format
51672130200
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
Non-Proprietary Name
Terconazole
Substance Name
Terconazole
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Vaginal - Administration into the vagina.
Active Ingredient(s)
TERCONAZOLE 8 mg/g
Pharmacologic Class
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
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA075953
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-06-2004
Listing Expiration
12-31-2026
Exclude Flag
N
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 51672-1302-0 identifies a specific commercial package of 1 tube, with applicator in 1 carton / 20 g in 1 tube, with applicator of Terconazole, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This cream is formulated for vaginal use and contains terconazole as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Sun Pharmaceutical Industries, Inc. on April 06, 2004. The current certification is valid through December 31, 2026.

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 Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51672130200. 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)
51672-1302-0
11-Digit CMS (5-4-2)
51672-1302-00

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