Miconazole Nitrate
NDC Package 55315-815-63

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 Nitrate is before using this product, read the enclosed consumer information leaflet for complete directions and informationadults and children 12 years of age and over:applicators: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Marketed by Fred's, Inc., this product is identified by NDC 55315-815 and is authorized under FDA application ANDA074444.

Identification & Billing

NDC Package Code
55315-815-63
Package Description
1 TUBE, WITH APPLICATOR in 1 CARTON / 45 g in 1 TUBE, WITH APPLICATOR
Product Code
55315-815
11-Digit Billing Format
55315081563
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Miconazole Nitrate
Dosage Form
-
Usage Information
Before using this product, read the enclosed consumer information leaflet for complete directions and informationadults and children 12 years of age and over:applicators: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw away applicator after each use.use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina (vulva). Use 2 times daily for up to 7 days as needed.children under 12 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Fred's, Inc.
FDA Application #
ANDA074444
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-13-1997
Listing Expiration
12-31-2025
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 55315-815-63 identifies a specific commercial package of 1 tube, with applicator in 1 carton / 45 g in 1 tube, with applicator of Miconazole Nitrate, labeled by Fred's, Inc.. 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 Fred's, Inc. on January 13, 1997. The current certification is valid through December 31, 2025.

How is this Fred's, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55315081563. 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)
55315-815-63
11-Digit CMS (5-4-2)
55315-0815-63

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