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  5. NDC Package Code: 11014-0385-1 Testosterone Undecanoate

NDC Package 11014-0385-1 Testosterone Undecanoate

Capsule - 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:
11014-0385-1
Package Description:
1 BAG in 1 BOX / 6000 CAPSULE in 1 BAG
Product Code:
11014-0385
Non-Proprietary Name:
Testosterone Undecanoate
Substance Name:
Testosterone Undecanoate
Usage Information:
This medication is used in men who do not make enough of a natural substance called testosterone. Testosterone belongs to a class of drugs known as androgens. Testosterone helps the body to develop and maintain 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. Testosterone may also be used in certain adolescent boys to cause puberty in those with delayed puberty. This product should not be used in women.
11-Digit NDC Billing Format:
11014038501
Product Type:
Drug For Further Processing
Labeler Name:
Catalent Pharma Solutions, Llc
Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Active Ingredient(s):
  • TESTOSTERONE UNDECANOATE 158 mg/1
    • DEA Schedule:
    Schedule III (CIII) Substances
    Sample Package:
    N/A
    Marketing Category:
    DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
    Start Marketing Date:
    08-18-2014
    Listing Expiration Date:
    12-31-2025
    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 11014-0385-1?

    The NDC Packaged Code 11014-0385-1 is assigned to an UNFINISHED drug package of 1 bag in 1 box / 6000 capsule in 1 bag of Testosterone Undecanoate, drug for further processing labeled by Catalent Pharma Solutions, Llc. The product's dosage form is capsule and is administered via form.

    Is NDC 11014-0385 included in the NDC Directory?

    Yes, Testosterone Undecanoate is an UNFINISHED PRODUCT with code 11014-0385 that is active and included in the NDC Directory. The product was first marketed by Catalent Pharma Solutions, Llc on August 18, 2014 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 11014-0385-1?

    The 11-digit format is 11014038501. 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
    5-4-111014-0385-15-4-211014-0385-01