FDA label
What is Depo-Testosterone used for?
Depo-Testosterone contains testosterone cypionate. The FDA-approved uses below are 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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Depo-Testosterone, 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 5 listings for this product.
Questions
What is Depo-Testosterone 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 Depo-Testosterone?
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.
More on Depo-Testosterone
- Is Depo-Testosterone a controlled substance?Schedule III
- What is Testosterone Cypionate used for?FDA label uses
- Is Testosterone Cypionate a controlled substance?Schedule III
- Androgens listFDA drug class
- NDC 0009-0085Depo-Testosterone NDC record
- NDC 0009-0086Depo-Testosterone NDC record
- NDC 0009-0347Depo-Testosterone NDC record
- Schedule III drugs listDEA schedule