Econazole Nitrate
NDC Package 0378-7625-85

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Econazole Nitrate is econazole is used to treat a variety of fungal skin infections such as athlete's foot, jock itch, and ringworm. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-7625 and is authorized under FDA application ANDA210364.

Identification & Billing

NDC Package Code
0378-7625-85
Package Description
1 TUBE in 1 CARTON / 85 g in 1 TUBE
Product Code
0378-7625
11-Digit Billing Format
00378762585
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
85 GM

Clinical Specifications

Proprietary Name
Econazole Nitrate
Dosage Form
-
Usage Information
Econazole is used to treat a variety of fungal skin infections such as athlete's foot, jock itch, and ringworm. This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. Econazole is an azole antifungal that works by preventing the growth of fungus.

Regulatory & Marketing

Labeler Name
Mylan Pharmaceuticals Inc.
FDA Application #
ANDA210364
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-02-2018
End Marketing Date
01-31-2020
Listing Expiration
01-31-2020
Exclude Flag
D
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0378-7625). Click a package code to view its specific billing and regulatory data.

0378-7625-15
1 TUBE in 1 CARTON / 15 g in 1 TUBE
0378-7625-49
1 TUBE in 1 CARTON / 30 g in 1 TUBE

* 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 0378-7625-85 identifies a specific commercial package of 1 tube in 1 carton / 85 g in 1 tube of Econazole Nitrate, labeled by Mylan Pharmaceuticals 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 Mylan Pharmaceuticals Inc. on October 02, 2018. The current certification is valid through January 31, 2020.

What are the primary indications for this medication?

Econazole is used to treat a variety of fungal skin infections such as athlete's foot, jock itch, and ringworm. This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. Econazole is an azole antifungal that works by preventing the growth of fungus.

How is this Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378762585. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 85 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 (4-4-2)
0378-7625-85
11-Digit CMS (5-4-2)
00378-7625-85

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