Miconazole Nitrate
NDC Package 55681-165-03

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 certification is expired.

Miconazole Nitrate is clean the affected area & dry thoroughlyapply a thin layer of the 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, & change shoes & socks at least once dailyfor athlete's foot & ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeksif condition persists longer, consult a doctorthis product is not effective on the scalp or nails. Marketed by Twin Med, Llc, this product is identified by NDC 55681-165 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
55681-165-03
Package Description
85 g in 1 BOTTLE, PLASTIC
Product Code
55681-165
11-Digit Billing Format
55681016503
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Miconazole Nitrate
Dosage Form
-
Usage Information
Clean the affected area & dry thoroughlyapply a thin layer of the 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, & change shoes & socks at least once dailyfor athlete's foot & ringworm, use daily for 4 weeks; for 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
Twin Med, Llc
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-19-2022
End Marketing Date
08-01-2028
Exclude Flag
E
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 55681-165-03 identifies a specific commercial package of 85 g in 1 bottle, plastic of Miconazole Nitrate, labeled by Twin Med, Llc. 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 Twin Med, Llc on August 19, 2022.

How is this Twin Med, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55681016503. 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)
55681-165-03
11-Digit CMS (5-4-2)
55681-0165-03

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