Miconazole Nitrate Antifungal Powder
NDC Package 10135-720-85

11-digit billing NDC: 10135072085 · Billing unit: GM · 85 GM per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Miconazole Nitrate Antifungal Powder powders is clean the affected area and dry thoroughlyApply a layer of power over affected area twice a day (morning and night) or as directed by a doctorSupervise children in the use of this productFor athlete's foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once dailyFor athlete's foot and ringworm, use daily for 4 weeksFor jock itch, use daily for 2 weeksIf condition persists longer, consult a doctorThis product is not effective on the scalp or nails. This formulation utilizes a powder delivery system. Marketed by Marlex Pharmaceuticals, Inc., this product is identified by NDC 10135-720 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
10135-720-85
Package Description
85 g in 1 BOTTLE
Product Code
10135-720
11-Digit Billing Format
10135072085
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
85 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Miconazole Nitrate Antifungal Powder
Non-Proprietary Name
Miconazole Nitrate Antifungal Powder
Substance Name
Miconazole Nitrate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
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)
MICONAZOLE NITRATE 2 g/100g
Pharmacologic Class
Usage Information
Clean the affected area and dry thoroughlyApply a layer of power over affected area twice a day (morning and night) or as directed by a doctorSupervise children in the use of this productFor athlete's foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once dailyFor athlete's foot and ringworm, use daily for 4 weeksFor jock itch, use daily for 2 weeksIf condition persists longer, consult a doctorThis product is not effective on the scalp or nails.

Regulatory & Marketing

Labeler Name
Marlex Pharmaceuticals, Inc.
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-01-2022
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 10135-720-85 identifies a specific commercial package of 85 g in 1 bottle of Miconazole Nitrate Antifungal Powder, a human over the counter drug labeled by Marlex Pharmaceuticals, Inc.. This product is billed per "GM" gram and contains an estimated amount of 85 billable units per package. This powder is formulated for topical use and contains miconazole nitrate 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 Marlex Pharmaceuticals, Inc. on May 01, 2022. The current certification is valid through December 31, 2026.

How is this Marlex Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10135072085. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 85 total billable units per package. 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)
10135-720-85
11-Digit CMS (5-4-2)
10135-0720-85

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