Topcare Tioconazole 1 Ointment
NDC Package 36800-426-54

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

Package Information

Topcare Tioconazole 1 (tioconazole) ointment is •before using this product read the enclosed brochure and instructions on printed packet for complete directions and information•adults and children 12 years of age and over:•open the printed packet just before use and remove purple cap•insert entire contents of applicator into the vagina at bedtime. This formulation utilizes a ointment delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 36800-426 and is authorized under FDA application ANDA075915.

Identification & Billing

NDC Package Code
36800-426-54
Package Description
1 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR
Product Code
36800-426
11-Digit Billing Format
36800042654
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
4.6 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Topcare Tioconazole 1
Non-Proprietary Name
Tioconazole
Substance Name
Tioconazole
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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)
TIOCONAZOLE 6.5 g/100g
Pharmacologic Class
Usage Information
•before using this product read the enclosed brochure and instructions on printed packet for complete directions and information•adults and children 12 years of age and over:•open the printed packet just before use and remove purple cap•insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use.•children under 12 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Topco Associates Llc
Product Type
Human Otc Drug
FDA Application #
ANDA075915
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-03-2008
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 36800-426-54 identifies a specific commercial package of 1 pouch in 1 carton / 1 applicator in 1 pouch / 4.6 g in 1 applicator of Topcare Tioconazole 1, a human over the counter drug labeled by Topco Associates Llc. This ointment is formulated for vaginal use and contains tioconazole 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 Topco Associates Llc on March 03, 2008. The current certification is valid through December 31, 2026.

How is this Topco Associates Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800042654. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 4.6 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)
36800-426-54
11-Digit CMS (5-4-2)
36800-0426-54

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