Monistat 1 Combination Pack
NDC Package 63736-014-03

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Monistat 1 Combination Pack is before using this product read the enclosed consumer information leaflet for complete directions and informationadults and children 12 years of age and over:vaginal insert: with the applicator, place the vaginal insert into the vagina. Marketed by Insight Pharmaceuticals, this product is identified by NDC 63736-014 and is authorized under FDA application NDA021308.

Identification & Billing

NDC Package Code
63736-014-03
Package Description
1 KIT in 1 PACKAGE, COMBINATION * 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBE
Product Code
63736-014
11-Digit Billing Format
63736001403
RxNorm Crosswalk
  • RxCUI: 992774 - miconazole nitrate 1200 MG Vaginal Insert
  • RxCUI: 992774 - miconazole nitrate 1.2 GM Vaginal Insert
  • RxCUI: 992775 - {1 (miconazole nitrate 1200 MG Vaginal Insert) / 1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) } Pack
  • RxCUI: 992775 - miconazole 1 day - (1200 MG insert / 2 % cream 9 GM) Pack
  • RxCUI: 992777 - Monistat 1200 MG Vaginal Insert

Clinical Specifications

Proprietary Name
Monistat 1 Combination Pack
Dosage Form
-
Usage Information
Before using this product read the enclosed consumer information leaflet for complete directions and informationadults and children 12 years of age and over:vaginal insert: with the applicator, place the vaginal insert into the vagina. Throw applicator away after use.external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina (vulva). Use 2 times daily for up to 7 days, as needed.children under 12 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Insight Pharmaceuticals
FDA Application #
NDA021308
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-29-2001
Listing Expiration
12-31-2019
Exclude Flag
I
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 63736-014-03 identifies a specific commercial package of 1 kit in 1 package, combination * 1 suppository in 1 pouch * 9 g in 1 tube of Monistat 1 Combination Pack, labeled by Insight Pharmaceuticals. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Insight Pharmaceuticals on June 29, 2001. The current certification is valid through December 31, 2019.

How is this Insight Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63736001403. 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)
63736-014-03
11-Digit CMS (5-4-2)
63736-0014-03

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