Leader Miconazole 3 Kit
NDC Package 70000-0669-1

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

Package Information

Leader Miconazole 3 (miconazole nitrate) kits is a medication used to treat vaginal yeast infections. This formulation utilizes a kit delivery system. Marketed by Cardinal Health 110, Llc. Dba Leader, this product is identified by NDC 70000-0669 and is authorized under FDA application ANDA076357.

Identification & Billing

NDC Package Code
70000-0669-1
Package Description
1 KIT in 1 CARTON * 1 APPLICATOR in 1 POUCH (0113-7198-00) / 5 g in 1 APPLICATOR * 1 TUBE in 1 CARTON (0113-8123-00) / 9 g in 1 TUBE
Product Code
70000-0669
11-Digit Billing Format
70000066901
RxNorm Crosswalk
  • RxCUI: 992816 - {1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (5000 MG) (miconazole nitrate 40 MG/ML Vaginal Cream) } Pack
  • RxCUI: 992816 - miconazole 3 Day - (4 % applicator 5 GM / 2 % cream 9 GM) Pack
  • RxCUI: 992816 - {3 (5 GM miconazole nitrate 200 MG (4 % ) Prefilled Applicator) / 1 (9 GM miconazole nitrate 2 % Vaginal Cream) } Pack
  • RxCUI: 992816 - {3 (5000 MG miconazole nitrate 4 % Prefilled Applicator) / 1 (0.32 OZ miconazole nitrate 2 % Vaginal Cream) } Pack
  • RxCUI: 992816 - Miconazole 3 Day Prefilled Applicator Combination Pack

Clinical Specifications

Proprietary Name
Leader Miconazole 3
Non-Proprietary Name
Miconazole Nitrate
Dosage Form
Kit - A packaged collection of related material.
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
Cardinal Health 110, Llc. Dba Leader
Product Type
Human Otc Drug
FDA Application #
ANDA076357
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-27-2024
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 70000-0669-1 identifies a specific commercial package of 1 kit in 1 carton * 1 applicator in 1 pouch (0113-7198-00) / 5 g in 1 applicator * 1 tube in 1 carton (0113-8123-00) / 9 g in 1 tube of Leader Miconazole 3, a human over the counter drug labeled by Cardinal Health 110, Llc. Dba Leader. This kit is formulated for use and contains 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 Cardinal Health 110, Llc. Dba Leader on June 27, 2024. The current certification is valid through December 31, 2026.

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 Cardinal Health 110, Llc. Dba Leader product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70000066901. 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 (5-4-1)
70000-0669-1
11-Digit CMS (5-4-2)
70000-0669-01

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