Prudoxin Cream
NDC Package 0378-8130-45

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

Package Information

Prudoxin (doxepin hydrochloride) cream is a medication used to relieve itching from certain skin conditions (e.g., atopic dermatitis, eczema, neurodermatitis). This formulation utilizes a cream delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-8130 and is authorized under FDA application NDA020126.

Identification & Billing

NDC Package Code
0378-8130-45
Package Description
1 TUBE in 1 CARTON / 45 g in 1 TUBE
Product Code
0378-8130
11-Digit Billing Format
00378813045
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
45 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Prudoxin
Non-Proprietary Name
Doxepin Hydrochloride
Substance Name
Doxepin Hydrochloride
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
DOXEPIN HYDROCHLORIDE 50 mg/g
Pharmacologic Class
Tricyclic Antidepressant - [EPC] (Established Pharmacologic Class)
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
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA020126
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-01-2018
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 0378-8130-45 identifies a specific commercial package of 1 tube in 1 carton / 45 g in 1 tube of Prudoxin, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. This product is billed per "GM" gram and contains an estimated amount of 45 billable units per package. This cream is formulated for topical use and contains doxepin hydrochloride 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 Mylan Pharmaceuticals Inc. on August 01, 2018. The current certification is valid through December 31, 2026.

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 Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378813045. 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 (4-4-2)
0378-8130-45
11-Digit CMS (5-4-2)
00378-8130-45

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