FDA label

What is testosterone cypionate used for?

The FDA-approved uses of testosterone cypionate, quoted from the Indications and Usage section of its DailyMed label.

Source: DailyMed SPL label file dated 2026-10-23. Publisher page

The FDA label says: “DEPO-Testosterone Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.”

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Testosterone Cypionate, injection, solution

Indications and Usage, quoted from the label by Pharmacia & Upjohn Company LLC (ANDA085635). Cross-references to other label sections are left out.

DEPO-Testosterone Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.

1. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.

2. Hypogonadotropic hypogonadism (congenital or acquired)- gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.

Safety and efficacy of DEPO-Testosterone (testosterone cypionate) in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

Source: DailyMed label, set id 735b5bf3-4464-412c-a072-1bd02f2e5380, version 16, effective July 14, 2025. NDC 0009-0085, one of 46 listings for this product.

Testosterone Cypionate, injection

Indications and Usage, quoted from the label by Wilshire Pharmaceuticals (ANDA206368). Cross-references to other label sections are left out.

Testosterone Cypionate Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.

1. Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.

2. Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropin or 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.

Source: DailyMed label, set id 58ff6e0d-cc0a-4455-8254-d883d26a3b6d, version 5, effective July 24, 2025. NDC 52536-625, one of 13 listings for this product.

Questions

What is testosterone cypionate used for?

The FDA label says: “DEPO-Testosterone Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.”

What drug class is testosterone cypionate?

FDA lists testosterone cypionate in the Androgen established pharmacologic class.

Does this page cover off-label uses or dosing?

No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.

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