Miconazole 3
NDC Package 37012-070-09

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 data was inactivated by the FDA.

Miconazole 3 is a medication used to treat vaginal yeast infections. Marketed by Shopko Stores Operating Co., Llc, this product is identified by NDC 37012-070 and is authorized under FDA application ANDA076773.

Identification & Billing

NDC Package Code
37012-070-09
Package Description
1 TUBE, WITH APPLICATOR in 1 CARTON / 25 g in 1 TUBE, WITH APPLICATOR
Product Code
37012-070
11-Digit Billing Format
37012007009
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Miconazole 3
Dosage Form
-
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
Shopko Stores Operating Co., Llc
FDA Application #
ANDA076773
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-02-2005
Listing Expiration
12-31-2019
Exclude Flag
I
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 37012-070-09 identifies a specific commercial package of 1 tube, with applicator in 1 carton / 25 g in 1 tube, with applicator of Miconazole 3, labeled by Shopko Stores Operating Co., 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 Shopko Stores Operating Co., Llc on March 02, 2005. The current certification is valid through December 31, 2019.

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 Shopko Stores Operating Co., Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 37012007009. 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)
37012-070-09
11-Digit CMS (5-4-2)
37012-0070-09

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