Testosterone Enanthate
NDC Package 62778-105-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Testosterone Enanthate is a medication used in men who do not make enough of a natural substance called testosterone. Marketed by Hikma Farmaceutica, this product is identified by NDC 62778-105 and is authorized under FDA application ANDA091120.

Identification & Billing

NDC Package Code
62778-105-01
Package Description
5 mL in 1 VIAL, MULTI-DOSE
Product Code
62778-105
11-Digit Billing Format
62778010501

Clinical Specifications

Proprietary Name
Testosterone Enanthate
Dosage Form
-
Usage Information
This medication is used in men who do not make enough of a natural substance called testosterone. In males, testosterone is responsible for many normal functions, including growth and development of the genitals, muscles, and bones. It also helps cause normal sexual development (puberty) in boys. Testosterone belongs to a class of drugs known as androgens. It works by affecting many body systems so that the body can develop and function normally. Testosterone may also be used in certain adolescent boys to cause puberty in those with delayed puberty. It may also be used to treat certain types of breast cancer in women.

Regulatory & Marketing

Labeler Name
Hikma Farmaceutica
FDA Application #
ANDA091120
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-18-2012
End Marketing Date
09-18-2012
Listing Expiration
09-18-2012
Exclude Flag
D
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 62778-105-01 identifies a specific commercial package of 5 ml in 1 vial, multi-dose of Testosterone Enanthate, labeled by Hikma Farmaceutica. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Hikma Farmaceutica on September 18, 2012. The current certification is valid through September 18, 2012.

What are the primary indications for this medication?

This medication is used in men who do not make enough of a natural substance called testosterone. In males, testosterone is responsible for many normal functions, including growth and development of the genitals, muscles, and bones. It also helps cause normal sexual development (puberty) in boys. Testosterone belongs to a class of drugs known as androgens. It works by affecting many body systems so that the body can develop and function normally. Testosterone may also be used in certain adolescent boys to cause puberty in those with delayed puberty. It may also be used to treat certain types of breast cancer in women.

How is this Hikma Farmaceutica product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62778010501. 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 (5-3-2)
62778-105-01
11-Digit CMS (5-4-2)
62778-0105-01

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