Xyosted Injection
NDC Package 54436-200-04
Package Information
Xyosted (testosterone enanthate) injection is a medication used by men who do not make enough of a natural substance called testosterone (hypogonadism). This formulation utilizes a injection delivery system. Marketed by Antares Pharma, Inc., this product is identified by NDC 54436-200 and is authorized under FDA application NDA209863.
Identification & Billing
- RxCUI: 2099681 - testosterone enanthate 100 MG in 0.5 ML Auto-Injector
- RxCUI: 2099681 - 0.5 ML testosterone enanthate 200 MG/ML Auto-Injector
- RxCUI: 2099681 - testosterone enanthate 100 MG per 0.5 ML Auto-Injector
- RxCUI: 2099686 - XYOSTED 100 MG in 0.5 ML Auto-Injector
- RxCUI: 2099686 - 0.5 ML testosterone enanthate 200 MG/ML Auto-Injector [Xyosted]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 54436 - Antares Pharma, Inc.
- 54436-200 - Xyosted
- 54436-200-04 - 4 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (54436-200-02)
- 54436-200 - Xyosted
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.
Other Available Packages
The following commercial packages are registered under the same Product NDC (54436-200). Click a package code to view its specific billing and regulatory data.
* 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 54436-200-04 identifies a specific commercial package of 4 syringe in 1 carton / .5 ml in 1 syringe (54436-200-02) of Xyosted, a human prescription drug labeled by Antares Pharma, Inc.. This injection is formulated for subcutaneous use and contains testosterone enanthate 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 Antares Pharma, Inc. on November 15, 2018. The current certification is valid through December 31, 2027.
What are the primary indications for this medication?
This medication is used by men who do not make enough of a natural substance called testosterone (hypogonadism). Testosterone belongs to a class of drugs known as androgens. 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.
How is this Antares Pharma, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 54436020004. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
