Hikma Testosterone Cypionate Injection USP, 200 mg/mL — 10 mL Multi-Dose Vial

Testosterone Cypionate Injection, USP is a clear, pale yellow, oleaginous sterile solution intended for intramuscular administration. It is indicated for replacement therapy in males with conditions associated with deficiency or absence of endogenous testosterone, including primary hypogonadism and hypogonadotropic hypogonadism. Safety and efficacy for age-related hypogonadism have not been established.

Package: One 10 mL multi-dose vial containing 200 mg/mL (2,000 mg total), NDC 0143-9726-01.

Formulation: Each mL contains testosterone cypionate USP 200 mg, benzyl benzoate USP 0.2 mL, cottonseed oil USP 560 mg, and benzyl alcohol USP 9.45 mg as a preservative. For intramuscular use only.

Storage and handling: Store at 20°C to 25°C (68°F to 77°F) under USP Controlled Room Temperature. Protect from light. Warming and shaking the vial can redissolve crystals that may form when stored below the recommended temperature.

Schedule III controlled substance; Rx only. Refer to the current prescribing information for complete indications, contraindications, warnings, precautions, dosing, and administration instructions.