Monistat Tioconazole 1 Ointment
NDC Package 63736-413-01

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

Package Information

Monistat Tioconazole 1 (tioconazole) ointment is before using this product read the enclosed brochure and instructions on foil packet for complete directions and informationadults and children 12 years of age and over:○ open the foil packet just before use and remove purple cap○ insert entire content of applicator into the vagina at bedtime. This formulation utilizes a ointment delivery system. Marketed by Insight Pharmaceuticals Llc, this product is identified by NDC 63736-413 and is authorized under FDA application ANDA075915.

Identification & Billing

NDC Package Code
63736-413-01
Package Description
1 APPLICATOR in 1 CARTON / 4.6 g in 1 APPLICATOR
Product Code
63736-413
11-Digit Billing Format
63736041301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Monistat 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
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
TIOCONAZOLE 6.5 g/100g
Pharmacologic Class
Usage Information
Before using this product read the enclosed brochure and instructions on foil packet for complete directions and informationadults and children 12 years of age and over:○ open the foil packet just before use and remove purple cap○ insert entire content 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
Insight Pharmaceuticals 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
11-21-2001
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 63736-413-01 identifies a specific commercial package of 1 applicator in 1 carton / 4.6 g in 1 applicator of Monistat Tioconazole 1, a human over the counter drug labeled by Insight Pharmaceuticals Llc. This ointment is formulated for topical 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 Insight Pharmaceuticals Llc on November 21, 2001. The current certification is valid through December 31, 2026.

How is this Insight Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63736041301. 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)
63736-413-01
11-Digit CMS (5-4-2)
63736-0413-01

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