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  5. NDC Package Code: 76003-1083-1 Testosterone

NDC Package 76003-1083-1 Testosterone

Powder - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:
76003-1083-1
Package Description:
1 g in 1 CONTAINER
Product Code:
76003-1083
Non-Proprietary Name:
Testosterone
Substance Name:
Testosterone
Usage Information:
This medicated patch contains testosterone. It is used for hormone replacement in men who are not able to produce enough testosterone (for example, due to 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:
76003108301
Product Type:
Bulk Ingredient
Labeler Name:
Fagron Services B.v.
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s):
  • TESTOSTERONE 1 g/g
    • DEA Schedule:
    Schedule III (CIII) Substances
    Sample Package:
    N/A
    Marketing Category:
    BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
    Start Marketing Date:
    08-14-2019
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    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 76003-1083-1?

    The NDC Packaged Code 76003-1083-1 is assigned to an UNFINISHED drug package of 1 g in 1 container of Testosterone, a bulk ingredient labeled by Fagron Services B.v.. The product's dosage form is powder and is administered via form.

    Is NDC 76003-1083 included in the NDC Directory?

    Yes, Testosterone is an UNFINISHED PRODUCT with code 76003-1083 that is active and included in the NDC Directory. The product was first marketed by Fagron Services B.v. on August 14, 2019 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 11-digit format for NDC 76003-1083-1?

    The 11-digit format is 76003108301. 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 5-4-1 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
    5-4-176003-1083-15-4-276003-1083-01