Miconazole Nitrate 2% Cream Antifungal
NDC Package 72071-101-21

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.

Miconazole Nitrate 2% Cream Antifungal is clean the affected area and dry thoroughly • Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a healthcare professional • Supervise children in the use of this product.For athlete's foot: • Use daily for 4 weeks. Marketed by Rtmh Enterprises Dba Research Technology Medical Home, this product is identified by NDC 72071-101 and is authorized under FDA application part333C.

Identification & Billing

NDC Package Code
72071-101-21
Package Description
1 TUBE in 1 BOX / 15 g in 1 TUBE
Product Code
72071-101
11-Digit Billing Format
72071010121
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Miconazole Nitrate 2% Cream Antifungal
Dosage Form
-
Usage Information
Clean the affected area and dry thoroughly • Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a healthcare professional • Supervise children in the use of this product.For athlete's foot: • Use daily for 4 weeks. If condition persists, consult a healthcare professional. • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks atleast once daily. For ringworm: Use daily for 4 weeks. If condition persists, consult a healthcare professional. For jock itch: Use daily for 2 weeks. If condition persists longer, consult a healthcare professional. This product is not effective on the scalp or nails.

Regulatory & Marketing

Labeler Name
Rtmh Enterprises Dba Research Technology Medical Home
FDA Application #
part333C
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
09-28-2018
Listing Expiration
12-31-2023
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 72071-101-21 identifies a specific commercial package of 1 tube in 1 box / 15 g in 1 tube of Miconazole Nitrate 2% Cream Antifungal, labeled by Rtmh Enterprises Dba Research Technology Medical Home. 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 Rtmh Enterprises Dba Research Technology Medical Home on September 28, 2018. The current certification is valid through December 31, 2023.

How is this Rtmh Enterprises Dba Research Technology Medical Home product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72071010121. 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)
72071-101-21
11-Digit CMS (5-4-2)
72071-0101-21

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