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  5. NDC Package Code: 63481-183-16 Fortesta

NDC Package 63481-183-16 Fortesta

Testosterone Gel, Metered 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:
63481-183-16
Package Description:
1 CANISTER in 1 CARTON / 60 g in 1 CANISTER
Product Code:
63481-183
Proprietary Name:
Fortesta
Non-Proprietary Name:
Testosterone
Substance Name:
Testosterone
Usage Information:
This medicated gel contains testosterone. It is used for hormone replacement in men who are not able to produce enough testosterone (hypogonadism). This medication is absorbed through the skin, enters your bloodstream, and helps your body reach normal testosterone levels. Testosterone helps the body to develop and maintain the male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire. This drug should not be used by women.
11-Digit NDC Billing Format:
63481018316
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
60 GM
NDC to RxNorm Crosswalk:
  • RxCUI: 1596781 - testosterone 10 MG/ACTUAT Transdermal Gel Pump, 120 ACTUAT
  • RxCUI: 1596781 - 120 ACTUAT testosterone 10 MG/ACTUAT Topical Gel
  • RxCUI: 1596783 - FORTESTA 10 MG/ACTUAT Transdermal Gel Pump, 120 ACTUAT
  • RxCUI: 1596783 - 120 ACTUAT testosterone 10 MG/ACTUAT Topical Gel [Fortesta]
  • RxCUI: 1596783 - Fortesta 10 MG/ACTUAT Transdermal Gel Pump, 120 ACTUAT
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Endo Pharmaceuticals Inc.
    Dosage Form:
    Gel, Metered - A gel preparation, with metered dose valves, which allow for the delivery of a uniform quantity of gel upon each activation.
    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):
  • TESTOSTERONE 10 mg/.5g
    • Pharmacologic Class(es):
  • Androgen Receptor Agonists - [MoA] (Mechanism of Action)
  • Androgen - [EPC] (Established Pharmacologic Class)
  • Androstanes - [CS]
    • DEA Schedule:
    Schedule III (CIII) Substances
    Sample Package:
    No
    FDA Application Number:
    NDA021463
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-29-2010
    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 63481-183-16?

    The NDC Packaged Code 63481-183-16 is assigned to a package of 1 canister in 1 carton / 60 g in 1 canister of Fortesta, a human prescription drug labeled by Endo Pharmaceuticals Inc.. The product's dosage form is gel, metered and is administered via topical form.

    Is NDC 63481-183 included in the NDC Directory?

    Yes, Fortesta with product code 63481-183 is active and included in the NDC Directory. The product was first marketed by Endo Pharmaceuticals Inc. on December 29, 2010 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 63481-183-16?

    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 60.

    What is the 11-digit format for NDC 63481-183-16?

    The 11-digit format is 63481018316. 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 5-3-2 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
    5-3-263481-183-165-4-263481-0183-16