Terconazole Suppository
NDC Package 45802-717-08

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

Package Information

Terconazole suppositories is a medication used to treat vaginal yeast infections. This formulation utilizes a suppository delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-717 and is authorized under FDA application ANDA077149.

Identification & Billing

NDC Package Code
45802-717-08
Package Description
3 BLISTER PACK in 1 CARTON / 1 SUPPOSITORY in 1 BLISTER PACK (45802-717-00)
Product Code
45802-717
11-Digit Billing Format
45802071708
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA
RxNorm Crosswalk
RxCUI: 198245 - terconazole 80 MG Vaginal Insert

Clinical Specifications

Proprietary Name
Terconazole
Non-Proprietary Name
Terconazole
Substance Name
Terconazole
Dosage Form
Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.
Administration Route
Vaginal - Administration into the vagina.
Active Ingredient(s)
TERCONAZOLE 80 mg/1
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
Padagis Israel Pharmaceuticals Ltd
Product Type
Human Prescription Drug
FDA Application #
ANDA077149
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-28-2006
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 45802-717-08 identifies a specific commercial package of 3 blister pack in 1 carton / 1 suppository in 1 blister pack (45802-717-00) of Terconazole, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. This suppository 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 Padagis Israel Pharmaceuticals Ltd on August 28, 2006. 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 Padagis Israel Pharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45802071708. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 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)
45802-717-08
11-Digit CMS (5-4-2)
45802-0717-08

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