What is testosterone used for?

Indications and Usage, quoted from the label by Encube Ethicals, Inc. (ANDA212984). Cross-references to other label sections are left out.

Testosterone gel, 1% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

• Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
• Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range.

Limitations of use:

• Safety and efficacy of testosterone gel, 1% in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.
• Safety and efficacy of testosterone gel, 1% in males less than 18 years old have not been established.
• Topical testosterone products may have different doses, strengths or application instructions that may result in different systemic exposure.

Source: DailyMed label, set id 7d655d6d-01da-488c-bd4e-c7fbe0ace38c, version 8, effective October 8, 2025. NDC 21922-019, one of 22 listings for this product.

Indications and Usage, quoted from the label by Encube Ethicals, Inc. (ANDA212301). Cross-references to other label sections are left out.

Testosterone Topical Solution is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

• Primary hypogonadism (congenital or acquired); testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum concentrations and gonadotropins (FSH, LH) above the normal range.
• Hypogonadotropic hypogonadism (congenital or acquired): gonadotropic or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma or radiation. These men have low testosterone serum-concentrations but have gonadotropins in the normal or low range.

Limitations of use:

• Safety and efficacy of Testosterone Topical Solution in men with “age-related hypogonadism' (also referred to as “late-onset hypogonadism”) have not been established.
• Safety and efficacy of Testosterone Topical Solution in males < 18 years old have not been established.

Source: DailyMed label, set id ca5d4865-356b-45e7-b603-fe299e450abc, version 2, effective July 6, 2026. NDC 21922-109, one of 8 listings for this product.