Testosterone Cypionate 200 mg/mL Injection, 1 mL
Other active recalls for Testosterone Cypionate (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Androgen class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Testosterone injection is used to treat low or no testosterone levels, stimulate puberty in males with delayed puberty, and certain types of breast cancer. Testosterone is in a class of medications called androgenic hormones. Testosterone is a male sex hormone responsible for development and functioning of male sexual organs and typical male characteristics. Testosterone injection works by replacing the testosterone that is normally produced naturally in the body. When used to treat breast cancer, testosterone works by stopping the release of estrogen.
Read the full MedlinePlus article ↗- Testosterone replacement is specifically for men whose bodies aren't making enough testosterone because of a medical condition — like a problem with the testes themselves (primary...
- What exactly is testosterone replacement therapy for — do I really need it?
- Yes, this is a serious concern. Children who accidentally touch the gel on your skin or clothing can absorb testosterone and develop early puberty signs — things like pubic hair gr...
- I use the gel — do I really need to worry about my kids or partner being exposed to it?
Patient education
Supplement & herbal interactions
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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9.45 mg / 1 mL
UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
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0.2 mL / 1 mL
UNII N863NB338G
Benzyl benzoate is a liquid organic compound used as a solvent and preservative in medicines. It helps dissolve active ingredients and can extend shelf life by preventing microbial growth in liquid formulations.
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560 mg / 1 mL
UNII H3E878020N
Cottonseed oil is a natural vegetable oil extracted from cotton plant seeds. It is used in medicines as a solvent and lubricant to help dissolve active ingredients and allow smooth tablet or capsule movement through manufacturing equipment.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $11.546 | $11.55 / 1 ml |
| Medicaid paysCMS SDUD · 12 mo | $12.64 | $12.64 / 1 ml |
| Medicare drug plans payPart D · Q2 2026 | $8.12 | $8.12 / 1 ml |
| Medicare Part B allowsASP · J1071 | $0.025 / J1071 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| testosterone cypionate 200 mg/mL 47781-0910-91 | Alvogen | 10 vials | $2.235 | AO | Availability likely | save 81% |
| Testosterone Cypionate 200 mg/mL 62756-0016-40 | Sun | 1 vial | $3.286 | — | FDA listed | save 72% |
| Testosterone Cypionate 200 mg/mL 00143-9726-01 | Hikma | 10 ml | $3.651 | AO | Availability likely | save 68% |
| Testosterone Cypionate 200 mg/mL 00143-9005-01 | Hikma | 1 vial | $3.651 | AO | Availability likely | save 68% |
| testosterone cypionate 200 mg/mL 70700-0290-22 | Xiromed | 1 vial | $3.651 | AO | Availability likely | save 68% |
| Testosterone Cypionate 200 mg/mL 62756-0015-40 | Sun | 1 vial | $11.349 | — | FDA listed | save 2% |
| Testosterone Cypionate 200 mg/mLthis 00143-9659-01 | Hikma | 1 ml | $11.546 | AO | Availability likely | — |
| Testosterone Cypionate 200 mg/mL 00409-6562-01 | Hospira, | 1 vial | $11.546 | AO | Availability likely | — |
| Testosterone Cypionate 200 mg/mL 00574-0820-01 | Padagis | 1 vial | $11.546 | AO | Availability likely | — |
| Testosterone Cypionate 200 mg/mL 00574-0827-01 | Padagis | 1 vial | $11.546 | AO | Availability likely | — |
| testosterone cypionate 200 mg/mL 47781-0911-93 | Alvogen | 1 vial | $11.546 | AO | Availability likely | — |
| Testosterone Cypionate 200 mg/mL 52536-0625-01 | Wilshire | 1 vial | $11.546 | AO | Availability likely | — |
| Testosterone Cypionate 200 mg/mL 55150-0277-01 | Eugia | 1 vial | $11.546 | AO | Availability likely | — |
| Testosterone Cypionate 200 mg/mL 69097-0537-31 | Cipla | 1 ml | $11.546 | AO | Availability likely | — |
| Testosterone Cypionate 200 mg/mL 69097-0802-32 | Cipla | 1 vial | $11.546 | AO | Availability likely | — |
| testosterone cypionate 200 mg/mL 70700-0289-22 | Xiromed | 1 vial | $11.546 | AO | Availability likely | — |
| testosterone cypionate 200 mg/mL 72603-0286-01 | NorthStar | 1 vial | $11.546 | AO | Availability likely | — |
| Depo-Testosterone 200 mg/mL 00009-0086-01 | Pharmacia | 1 vial | $14.140 | AO | Availability likely | +22% |
| Depo-Testosterone 200 mg/mL 00009-0417-01 | Pharmacia | 1 vial | $14.140 | AO | Availability likely | +22% |
| Testosterone Cypionate 200 mg/mL 00517-1830-01 | American | 1 vial | $14.181 | AO | Discontinued | +23% |
| Azmiro 200 mg/mL 24338-0056-01 | Azurity | 1 vial | — | — | FDA listed | — |
| testosterone cypionate 200 mg/mL 50090-7584-00 | A-S | 1 vial | — | AO | FDA listed | — |
| testosterone cypionate 200 mg/mL 50090-7585-00 | A-S | 1 vial | — | AO | FDA listed | — |
| Testosterone Cypionate 200 mg/mL 63629-8705-01 | Bryant | 1 vial | — | AO | FDA listed | — |
| testosterone cypionate 200 mg/mL 68071-3835-01 | NuCare | 1 vial | — | AO | FDA listed | — |
| Testosterone Cypionate 200 mg/mL 70518-4538-00 | REMEDYREPACK | 1 ml | — | AO | FDA listed | — |
| Testosterone Cypionate 200 mg/mL 71205-0289-01 | Proficient | 1 ml | — | AO | FDA listed | — |
| Testosterone Cypionate 200 mg/mL 71335-2470-01 | Bryant | 1 vial | — | AO | FDA listed | — |
| Testosterone Cypionate 200 mg/mL 71335-2838-01 | Bryant | 1 vial | — | AO | FDA listed | — |
| Testosterone Cypionate 200 mg/mL 72162-1119-02 | Bryant | 1 vial | — | AO | FDA listed | — |
| Testosterone Cypionate 200 mg/mL 72162-2348-02 | Bryant | 1 vial | — | AO | FDA listed | — |
| Testosterone Cypionate 200 mg/mL 72162-2375-02 | Bryant | 1 vial | — | AO | FDA listed | — |
| Testosterone Cypionate 200 mg/mL 76420-0746-01 | Asclemed | 1 vial | — | AO | FDA listed | — |
| testosterone cypionate 200 mg/mL 76420-0747-01 | Asclemed | 1 vial | — | AO | FDA listed | — |
| Testosterone Cypionate 200 mg/mL 63187-0647-10 | Proficient | 10 ml | — | AO | FDA listed | — |
| Testosterone Cypionate 200 mg/mL 76420-0065-10 | Asclemed | 10 ml | — | AO | FDA listed | — |
| Testosterone Cypionate 200 mg/mL 63629-8706-01 | Bryant | 1 vial | — | AO | FDA listed | — |
| Testosterone Cypionate 200 mg/mL 76420-0645-10 | Asclemed | 1 vial | — | AO | FDA listed | — |
| Testosterone Cypionate 200 mg/mL 76420-0741-10 | Asclemed | 1 vial | — | AO | FDA listed | — |
| Azmiro 200 mg/mL 24338-0055-01 | Azurity | 1 syringe | — | — | FDA listed | — |
| testosterone cypionate 200 mg/mL 68071-3840-01 | NuCare | 10 vials | — | AO | FDA listed | — |
| Testosterone Cypionate 200 mg/mL 50090-4147-00 | A-S | 1 vial | — | AO | FDA listed | — |
| Testosterone Cypionate 200 mg/mL 50090-7435-00 | A-S | 1 vial | — | AO | FDA listed | — |
| Testosterone Cypionate 200 mg/mL 68071-3809-01 | NuCare | 1 vial | — | AO | FDA listed | — |
| Testosterone Cypionate 200 mg/mL 50090-4920-00 | A-S | 1 vial | — | AO | FDA listed | — |
| testosterone cypionate 200 mg/mL 76420-0752-10 | Asclemed | 1 vial | — | AO | FDA listed | — |
| Testosterone Cypionate 200 mg/mL 71335-2473-01 | Bryant | 1 vial | — | AO | FDA listed | — |
| Testosterone Cypionate 200 mg/mL 87063-0272-10 | ASCLEMED | 1 vial | — | AO | FDA listed | — |
| testosterone cypionate 200 mg/mL 82983-0425-01 | Ajenat | 1 vial | — | — | FDA listed | — |
| testosterone cypionate 200 mg/mL 82983-0424-01 | Ajenat | 1 vial | — | — | FDA listed | — |
| testosterone cypionate 200 mg/mL 54288-0150-01 | BPI | 1 vial | — | — | FDA listed | — |
| testosterone cypionate 200 mg/mL 54288-0156-01 | BPI | 1 vial | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00143-9659-01 You're viewing this | 1 mL in 1 VIAL (0143-9659-01) | 2012-05-01 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (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.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Prior to initiating testosterone cypionate, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range. Testosterone cypionate injection is for intramuscular use only. It should not be given intravenously.
Intramuscular injections should be given deep in the gluteal muscle. The suggested dosage for testosterone cypionate injection varies depending on the age, sex, and diagnosis of the individual patient. Dosage is adjusted according to the patient's response and the appearance of adverse reactions.
Various dosage regimens have been used to induce pubertal changes in hypogonadal males; some experts have advocated lower dosages initially, gradually increasing the dose as puberty progresses, with or without a decrease to maintenance levels. Other experts emphasize that higher dosages are needed to induce pubertal changes and lower dosages can be used for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose.
For replacement in the hypogonadal male, 50 to 400 mg should be administered every two to four weeks. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Warming and shaking the vial should redissolve any crystals that may have formed during storage at temperatures lower than recommended.
⛔ Contraindications ▾
CONTRAINDICATIONS Known hypersensitivity to the drug Males with carcinoma of the breast Males with known or suspected carcinoma of the prostate gland Women who are pregnant (see PRECAUTIONS, Pregnancy ) Patients with serious cardiac, hepatic or renal disease (see WARNINGS )
⚠️ Warnings ▾
WARNINGS Hypercalcemia may occur in immobilized patients. If this occurs, the drug should be discontinued. Prolonged use of high doses of androgens (principally the 17-α alkyl-androgens) has been associated with development of hepatic adenomas, hepatocellular carcinoma, and peliosis hepatis - all potentially life-threatening complications.
Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking. There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as testosterone cypionate. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE.
If a venous thromboembolic event is suspected, discontinue treatment with testosterone cypionate and initiate appropriate workup and management. Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use.
Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use testosterone cypionate. Testosterone can increase blood pressure which can increase cardiovascular (CV) risk over time.
Monitor blood pressure periodically in men using testosterone products, especially in men with hypertension. Testosterone products are not recommended for use in patients with uncontrolled hypertension. Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids.
Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions (see DRUG ABUSE AND DEPENDENCE ). If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives.
Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events. Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal or hepatic disease.
Gynecomastia may develop and occasionally persists in patients being treated for hypogonadism. The preservative benzyl alcohol has been associated with serious adverse events, including the “gasping syndrome”, and death in pediatric patients. Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome”, the minimum amount of benzyl alcohol at which toxicity may occur is not known.
The risk of benzyl alcohol toxicity depends on the quantity administered and the liver and kidneys' capacity to detoxify the chemical. Premature and low-birth weight infants may be more likely to develop toxicity. Androgen therapy should be used cautiously in healthy males with delayed puberty.
The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every 6 months. In children, androgen treat…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following adverse reactions in the male have occurred with some androgens: Endocrine and urogenital: Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages. Skin and appendages: Hirsutism, male pattern of baldness, seborrhea, and acne.
Cardiovascular Disorders : Myocardial infarction, stroke Fluid and electrolyte disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates. Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular neoplasms and peliosis hepatis (see WARNINGS ). Hematologic: Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.
Nervous system: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia. Allergic: Hypersensitivity, including skin manifestations and anaphylactoid reactions. Vascular Disorders: Venous thromboembolism.
Special senses: Rare cases of central serous chorioretinopathy (CSCR). Miscellaneous: Inflammation and pain at the site of intramuscular injection. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
Drug interactions Androgens may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may require reduction in order to maintain satisfactory therapeutic hypoprothrombinemia. Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.
🔄 Drug / Laboratory Test Interactions ▾
Drug/Laboratory test Interferences Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T 4 serum levels and increased resin uptake of T 3 and T 4 . Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects The use of testosterone in women who are pregnant is contraindicated. Testosterone is teratogenic and may cause fetal harm. Testosterone is known to cause virilization of the female fetus when administrated to pregnant women. Benzyl alcohol can cross the placenta. See WARNINGS .
🧒 Pediatric Use ▾
Pediatric use Safety and effectiveness in pediatric patients below the age of 12 years have not been established.
🆘 Overdosage ▾
OVERDOSAGE There have been no reports of acute overdosage with the androgens.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Endogenous androgens are responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include growth and maturation of the prostate, seminal vesicles, penis, and scrotum; development of male hair distribution, such as beard, pubic, chest, and axillary hair; laryngeal enlargement, vocal cord thickening, and alterations in body musculature and fat distribution. Drugs in this class also cause retention of nitrogen, sodium, potassium, and phosphorus, and decreased urinary excretion of calcium.
Androgens have been reported to increase protein anabolism and decrease protein catabolism. Nitrogen balance is improved only when there is sufficient intake of calories and protein. Androgens are responsible for the growth spurt of adolescence and for eventual termination of linear growth, brought about by fusion of the epiphyseal growth centers.
In children, exogenous androgens accelerate linear growth rates, but may cause disproportionate advancement in bone maturation. Use over long periods may result in fusion of the epiphyseal growth centers and termination of the growth process. Androgens have been reported to stimulate production of red blood cells by enhancing production of erythropoietic stimulation factor.
During exogenous administration of androgens, endogenous testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). At large doses of exogenous androgens, spermatogenesis may also be suppressed through feedback inhibition of pituitary follicle stimulating hormone (FSH). There is a lack of substantial evidence that androgens are effective in fractures, surgery, convalescence, and functional uterine bleeding.
Pharmacokinetics Testosterone esters are less polar than free testosterone. Testosterone esters in oil injected intramuscularly are absorbed slowly from the lipid phase; thus, testosterone cypionate can be given at intervals of two to four weeks. Testosterone in plasma is 98 percent bound to a specific testosterone-estradiol binding globulin, and about 2 percent is free.
Generally, the amount of this sex-hormone binding globulin in the plasma will determine the distribution of testosterone between free and bound forms, and the free testosterone concentration will determine its half-life. About 90 percent of a dose of testosterone is excreted in the urine as glucuronic and sulfuric acid conjugates of testosterone and its metabolites; about 6 percent of a dose is excreted in the feces, mostly in the unconjugated form. Inactivation of testosterone occurs primarily in the liver.
Testosterone is metabolized to various 17-keto steroids through two different pathways. The half-life of testosterone cypionate when injected intramuscularly is approximately eight days. In many tissues the activity of testosterone appears to depend on reduction to dihydrotestosterone, which binds to cytosol receptor proteins.
The steroid-receptor complex is transported to the nucleus where it initiates transcription events and cellular changes related to androgen action.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Testosterone Cypionate Injection, USP, 200 mg/mL is a clear, pale yellow oleaginous viscous, sterile solution intended for intramuscular administration available as: 1 mL Vial, Carton of 1 vial NDC 0143-9659-01 10 mL Multiple Dose Vial, Carton of 1 vial NDC 0143-9726-01 Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from light. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A.
Estrada do Rio da Mό, 8A e 8B - Fervença, - 2705-906 Terrugem SNT, PORTUGAL Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised: June 2025 PIN300-WES/14
📋 Description ▾
DESCRIPTION Testosterone Cypionate Injection, USP for intramuscular injection, contains Testosterone Cypionate, USP which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone Cypionate, USP is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils.
The chemical name for Testosterone Cypionate, USP is androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C 27 H 40 O 3 , and the molecular weight 412.61. The structural formula is represented below: Testosterone Cypionate Injection, USP is available in one strength, 200 mg/mL Testosterone Cypionate, USP.
Each mL of the 200 mg/mL solution contains: Testosterone Cypionate, USP 200 mg Benzyl Benzoate, USP 0.2 mL Cottonseed Oil, USP 560 mg Benzyl Alcohol, USP (as preservative) 9.45 mg Chemical Structure
💬 Information for Patients ▾
Information for patients Patients should be instructed to report any of the following: nausea, vomiting, changes in skin color, ankle swelling, too frequent or persistent erections of the penis.