Zonalon
NDC Package 10337-804-45

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.

Zonalon is a medication used to relieve itching from certain skin conditions (e.g., atopic dermatitis, eczema, neurodermatitis). Marketed by Pharmaderm A Division Of Fougera Pharmaceuticals Inc., this product is identified by NDC 10337-804 and is authorized under FDA application NDA020126.

Identification & Billing

NDC Package Code
10337-804-45
Package Description
1 TUBE in 1 CARTON / 45 g in 1 TUBE
Product Code
10337-804
11-Digit Billing Format
10337080445
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
45 GM

Clinical Specifications

Proprietary Name
Zonalon
Dosage Form
-
Usage Information
This medication is used to relieve itching from certain skin conditions (e.g., atopic dermatitis, eczema, neurodermatitis). It should be used only for a short time (no more than 8 days). Doxepin is a tricyclic antidepressant. It is not known how this medication decreases itching. Some medication is absorbed into the body when the cream is applied. This medication may work by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. The decrease in itching may be a result of drowsiness or some other effect in the brain that causes you not to notice or be bothered by the itching.

Regulatory & Marketing

Labeler Name
Pharmaderm A Division Of Fougera Pharmaceuticals Inc.
FDA Application #
NDA020126
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-01-1994
End Marketing Date
02-28-2017
Listing Expiration
02-28-2017
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 (10337-804). Click a package code to view its specific billing and regulatory data.

10337-804-03
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 10337-804-45 identifies a specific commercial package of 1 tube in 1 carton / 45 g in 1 tube of Zonalon, labeled by Pharmaderm A Division Of Fougera 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 Pharmaderm A Division Of Fougera Pharmaceuticals Inc. on April 01, 1994. The current certification is valid through February 28, 2017.

What are the primary indications for this medication?

This medication is used to relieve itching from certain skin conditions (e.g., atopic dermatitis, eczema, neurodermatitis). It should be used only for a short time (no more than 8 days). Doxepin is a tricyclic antidepressant. It is not known how this medication decreases itching. Some medication is absorbed into the body when the cream is applied. This medication may work by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. The decrease in itching may be a result of drowsiness or some other effect in the brain that causes you not to notice or be bothered by the itching.

How is this Pharmaderm A Division Of Fougera Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10337080445. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 45 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)
10337-804-45
11-Digit CMS (5-4-2)
10337-0804-45

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