Monistat 3 Combination Pack Kit
NDC Package 63736-010-01

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

Package Information

Monistat 3 Combination Pack (miconazole nitrate) kits is a medication used to treat vaginal yeast infections. This formulation utilizes a kit delivery system. Marketed by Insight Pharmaceuticals Llc, this product is identified by NDC 63736-010 and is authorized under FDA application NDA021261.

Identification & Billing

NDC Package Code
63736-010-01
Package Description
1 KIT in 1 PACKAGE, COMBINATION * 5 g in 1 APPLICATOR * 9 g in 1 TUBE
Product Code
63736-010
11-Digit Billing Format
63736001001
RxNorm Crosswalk
  • RxCUI: 1536604 - {1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]) / 3 (5000 MG) (miconazole nitrate 40 MG/ML Vaginal Cream [Monistat]) } Pack [Monistat 3 Vaginal Cream Combination Pack with Vaginal Creams]
  • RxCUI: 1536604 - Monistat 3 Vaginal Cream and Topical Cream Combination Pack with Prefilled Applicators
  • RxCUI: 992816 - {1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (5000 MG) (miconazole nitrate 40 MG/ML Vaginal Cream) } Pack
  • RxCUI: 992816 - miconazole 3 Day - (4 % applicator 5 GM / 2 % cream 9 GM) Pack
  • RxCUI: 992816 - {3 (5 GM miconazole nitrate 200 MG (4 % ) Prefilled Applicator) / 1 (9 GM miconazole nitrate 2 % Vaginal Cream) } Pack

Clinical Specifications

Proprietary Name
Monistat 3 Combination Pack
Non-Proprietary Name
Miconazole Nitrate
Dosage Form
Kit - A packaged collection of related material.
Usage Information
This medication is used to treat vaginal yeast infections. Miconazole 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. The vaginal product comes in 2 forms (a vaginal cream or tablet). Some products also come with a skin cream to be applied to the area around the outside of the vagina. Ask your doctor before using this medication for self-treatment if this is your first vaginal infection. This medication only works for vaginal fungal infections. You may have a different type of infection (such as bacterial vaginosis) and may need a different medication. If you have fever, chills, flu-like symptoms, stomach/abdominal pain, or a bad-smelling vaginal discharge, do not use this medication. Contact your doctor right away because these may be signs of a more serious infection.

Regulatory & Marketing

Labeler Name
Insight Pharmaceuticals Llc
Product Type
Human Otc Drug
FDA Application #
NDA021261
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-10-2009
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 63736-010-01 identifies a specific commercial package of 1 kit in 1 package, combination * 5 g in 1 applicator * 9 g in 1 tube of Monistat 3 Combination Pack, a human over the counter drug labeled by Insight Pharmaceuticals Llc. This kit is formulated for use and contains 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 December 10, 2009. 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. Miconazole 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. The vaginal product comes in 2 forms (a vaginal cream or tablet). Some products also come with a skin cream to be applied to the area around the outside of the vagina. Ask your doctor before using this medication for self-treatment if this is your first vaginal infection. This medication only works for vaginal fungal infections. You may have a different type of infection (such as bacterial vaginosis) and may need a different medication. If you have fever, chills, flu-like symptoms, stomach/abdominal pain, or a bad-smelling vaginal discharge, do not use this medication. Contact your doctor right away because these may be signs of a more serious infection.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63736001001. 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)
63736-010-01
11-Digit CMS (5-4-2)
63736-0010-01

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