Testosterone Cypionate Injection, Solution
NDC Package 47781-910-91

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

Package Information

Testosterone Cypionate injection is a medication used in men who do not make enough of a natural substance called testosterone. This formulation utilizes a injection, solution delivery system. Marketed by Alvogen Inc., this product is identified by NDC 47781-910 and is authorized under FDA application ANDA207742.

Identification & Billing

NDC Package Code
47781-910-91
Package Description
10 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE (47781-910-22)
Product Code
47781-910
11-Digit Billing Format
47781091091
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

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
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.
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Alvogen Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA207742
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-02-2022
Listing Expiration
12-31-2026
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 47781-910-91 identifies a specific commercial package of 10 vial, multi-dose in 1 carton / 10 ml in 1 vial, multi-dose (47781-910-22) of Testosterone Cypionate, a human prescription drug labeled by Alvogen Inc.. 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 Alvogen Inc. on November 02, 2022. The current certification is valid through December 31, 2026.

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 Alvogen Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47781091091. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
47781-910-91
11-Digit CMS (5-4-2)
47781-0910-91

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