Testosterone Cypionate Injection, Solution
NDC Package 50090-8127-0

11-digit billing NDC: 50090812700
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Testosterone Cypionate injection is uSP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.Safety and efficacy of testosterone cypionate in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. This formulation utilizes a injection, solution delivery system. Marketed by A-s Medication Solutions, this product is identified by NDC 50090-8127 and is authorized under FDA application ANDA091244.

Identification & Billing

NDC Package Code
50090-8127-0
Package Description
1 VIAL, GLASS in 1 CARTON / 1 mL in 1 VIAL, GLASS
Product Code
50090-8127
11-Digit Billing Format
50090812700

Clinical Specifications

Proprietary Name
Testosterone Cypionate
Non-Proprietary Name
Testosterone Cypionate
Substance Name
Testosterone Cypionate
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
TESTOSTERONE CYPIONATE 200 mg/mL
Pharmacologic Class
Usage Information
Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.Safety and efficacy of testosterone cypionate in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
A-s Medication Solutions
Product Type
Human Prescription Drug
FDA Application #
ANDA091244
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-26-2019
Listing Expiration
12-31-2027
Exclude Flag
N
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 50090-8127-0 identifies a specific commercial package of 1 vial, glass in 1 carton / 1 ml in 1 vial, glass of Testosterone Cypionate, a human prescription drug labeled by A-s Medication Solutions. This injection, solution is formulated for intramuscular use and contains testosterone cypionate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by A-s Medication Solutions on March 26, 2019. The current certification is valid through December 31, 2027.

How is this A-s Medication Solutions product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50090812700. 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 (5-4-1)
50090-8127-0
11-Digit CMS (5-4-2)
50090-8127-00

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