Monistat 3 Combination Pack
NDC Package 57501-006-01

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 3 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:applicators: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Marketed by Apex International Mfg., Inc., this product is identified by NDC 57501-006 and is authorized under FDA application NDA020670.

Identification & Billing

NDC Package Code
57501-006-01
Package Description
1 KIT in 1 PACKAGE, COMBINATION * 5 g in 1 APPLICATOR * 9 g in 1 TUBE
Product Code
57501-006
11-Digit Billing Format
57501000601
RxNorm Crosswalk
  • RxCUI: 992765 - miconazole nitrate 200 MG Vaginal Insert
  • RxCUI: 992766 - {1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } Pack
  • RxCUI: 992766 - miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) Pack
  • RxCUI: 992766 - miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)
  • RxCUI: 992766 - miconazole 3 Day Vaginal Insert Combination Pack

Clinical Specifications

Proprietary Name
Monistat 3 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:applicators: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Throw away applicator after use. external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed. children under 12 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Apex International Mfg., Inc.
FDA Application #
NDA020670
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-11-2020
Listing Expiration
12-31-2021
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 57501-006-01 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, labeled by Apex International Mfg., Inc.. 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 Apex International Mfg., Inc. on June 11, 2020. The current certification is valid through December 31, 2021.

How is this Apex International Mfg., Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57501000601. 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)
57501-006-01
11-Digit CMS (5-4-2)
57501-0006-01

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