Miconazole Nitrate
NDC Package 36800-385-25

11-digit billing NDC: 36800038525 · Billing unit: GM · 71 GM per package
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 discontinued by the firm.

Miconazole Nitrate is clean the affected area and dry thoroughlyapply a thin layer of product over affected area twice daily (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 the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once dailyfor athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeksif conditions persist longer, consult a doctorthis product is not effective on the scalp or nails. Marketed by Topco Associates Llc, this product is identified by NDC 36800-385 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
36800-385-25
Package Description
71 g in 1 BOTTLE, PLASTIC
Product Code
36800-385
11-Digit Billing Format
36800038525
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
71 GM

Clinical Specifications

Proprietary Name
Miconazole Nitrate
Dosage Form
-
Usage Information
Clean the affected area and dry thoroughlyapply a thin layer of product over affected area twice daily (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 the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once dailyfor athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeksif conditions persist longer, consult a doctorthis product is not effective on the scalp or nails

Regulatory & Marketing

Labeler Name
Topco Associates Llc
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-07-2017
End Marketing Date
09-30-2026
Listing Expiration
09-30-2026
Exclude Flag
D
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 36800-385-25 identifies a specific commercial package of 71 g in 1 bottle, plastic of Miconazole Nitrate, labeled by Topco Associates Llc. This product is billed per "GM" gram and contains an estimated amount of 71 billable units per package. 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 Topco Associates Llc on December 07, 2017. The current certification is valid through September 30, 2026.

How is this Topco Associates Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800038525. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 71 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)
36800-385-25
11-Digit CMS (5-4-2)
36800-0385-25

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