Miconazole Cream
NDC Package 81993-010-01

11-digit billing NDC: 81993001001
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Miconazole (miconazole nitrate) cream is clean the affected area and dry thoroughlyApply a thin layer of the product over affected area twice daily (morning and night) or as directed by a healthcare professionalSupervise children in the use of this product.For athlete's foot: Use daily for 4 weeks. This formulation utilizes a cream delivery system. Marketed by Zennova Llc, this product is identified by NDC 81993-010 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
81993-010-01
Package Description
1 TUBE in 1 CARTON / 30 g in 1 TUBE
Product Code
81993-010
11-Digit Billing Format
81993001001

Clinical Specifications

Proprietary Name
Miconazole
Non-Proprietary Name
Miconazole Nitrate
Substance Name
Miconazole Nitrate
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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 20 mg/g
Pharmacologic Class
Usage Information
Clean the affected area and dry thoroughlyApply a thin layer of the product over affected area twice daily (morning and night) or as directed by a healthcare professionalSupervise 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 at least 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
Zennova Llc
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-16-2026
Listing Expiration
12-31-2027
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 81993-010-01 identifies a specific commercial package of 1 tube in 1 carton / 30 g in 1 tube of Miconazole, a human over the counter drug labeled by Zennova Llc. This cream 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 Zennova Llc on October 16, 2026. The current certification is valid through December 31, 2027.

How is this Zennova Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81993001001. 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)
81993-010-01
11-Digit CMS (5-4-2)
81993-0010-01

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