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  5. NDC Package Code: 0378-8130-45 Prudoxin

NDC Package 0378-8130-45 Prudoxin

Doxepin Hydrochloride Cream Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0378-8130-45
Package Description:
1 TUBE in 1 CARTON / 45 g in 1 TUBE
Product Code:
0378-8130
Proprietary Name:
Prudoxin
Non-Proprietary Name:
Doxepin Hydrochloride
Substance Name:
Doxepin Hydrochloride
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.
11-Digit NDC Billing Format:
00378813045
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
45 GM
NDC to RxNorm Crosswalk:
  • RxCUI: 1000091 - doxepin HCl 5 % Topical Cream
  • RxCUI: 1000091 - doxepin hydrochloride 50 MG/ML Topical Cream
  • RxCUI: 1000091 - doxepin hydrochloride 5 % Topical Cream
  • RxCUI: 1000093 - Prudoxin 5 % Topical Cream
  • RxCUI: 1000093 - doxepin hydrochloride 50 MG/ML Topical Cream [Prudoxin]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mylan Pharmaceuticals Inc.
    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(s):
  • 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(es):
  • Tricyclic Antidepressant - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA020126
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    08-01-2018
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 0378-8130-45?

    The NDC Packaged Code 0378-8130-45 is assigned to a package of 1 tube in 1 carton / 45 g in 1 tube of Prudoxin, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is cream and is administered via topical form.This product is billed per "GM" gram and contains an estimated amount of 45 billable units per package.

    Is NDC 0378-8130 included in the NDC Directory?

    Yes, Prudoxin with product code 0378-8130 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on August 01, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0378-8130-45?

    The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 45.

    What is the 11-digit format for NDC 0378-8130-45?

    The 11-digit format is 00378813045. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20378-8130-455-4-200378-8130-45