Triple Antifungal Ointment
NDC Package 16864-040-02

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Triple Antifungal (miconazole nitrate) ointment is a medication used to treat vaginal yeast infections. This formulation utilizes a ointment delivery system. Marketed by Advantice Health, Llc, this product is identified by NDC 16864-040 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
16864-040-02
Package Description
1 TUBE in 1 CARTON / 56.7 g in 1 TUBE
Product Code
16864-040
11-Digit Billing Format
16864004002
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
56.7 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Triple Antifungal
Non-Proprietary Name
Miconazole Nitrate
Substance Name
Miconazole Nitrate
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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 2 g/100g
Pharmacologic Class
Usage Information
This medication is used to treat vaginal yeast infections. Miconazole reduces vaginal burning, itching, and discharge that may occur with this condition. This medication is an azole antifungal. It works by stopping the growth of yeast (fungus) that causes the infection. The vaginal product comes in 2 forms (a vaginal cream or tablet). Some products also come with a skin cream to be applied to the area around the outside of the vagina. Ask your doctor before using this medication for self-treatment if this is your first vaginal infection. This medication only works for vaginal fungal infections. You may have a different type of infection (such as bacterial vaginosis) and may need a different medication. If you have fever, chills, flu-like symptoms, stomach/abdominal pain, or a bad-smelling vaginal discharge, do not use this medication. Contact your doctor right away because these may be signs of a more serious infection.

Regulatory & Marketing

Labeler Name
Advantice Health, Llc
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-01-2021
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 16864-040-02 identifies a specific commercial package of 1 tube in 1 carton / 56.7 g in 1 tube of Triple Antifungal, a human over the counter drug labeled by Advantice Health, Llc. This product is billed per "GM" gram and contains an estimated amount of 56.7 billable units per package. This ointment 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 Advantice Health, Llc on September 01, 2021. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat vaginal yeast infections. Miconazole reduces vaginal burning, itching, and discharge that may occur with this condition. This medication is an azole antifungal. It works by stopping the growth of yeast (fungus) that causes the infection. The vaginal product comes in 2 forms (a vaginal cream or tablet). Some products also come with a skin cream to be applied to the area around the outside of the vagina. Ask your doctor before using this medication for self-treatment if this is your first vaginal infection. This medication only works for vaginal fungal infections. You may have a different type of infection (such as bacterial vaginosis) and may need a different medication. If you have fever, chills, flu-like symptoms, stomach/abdominal pain, or a bad-smelling vaginal discharge, do not use this medication. Contact your doctor right away because these may be signs of a more serious infection.

How is this Advantice Health, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16864004002. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 56.7 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)
16864-040-02
11-Digit CMS (5-4-2)
16864-0040-02

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