Testosterone cypionate

Name: Testosterone cypionate

Brand names

  • Aveed®
  • Delatestryl®
  • Depo-Testosterone®
  • Testopel®

What is the most important information I should know about Testosterone Cypionate (testosterone injection)?

Do not use this medicine if you are pregnant or may become pregnant.

You should not receive testosterone if you have prostate cancer, male breast cancer, a serious heart condition, or severe liver or kidney disease.

Misuse of testosterone can cause dangerous or irreversible effects. Testosterone injections should be given only by a healthcare professional.

Testosterone Cypionate (testosterone injection) side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • nausea or vomiting;

  • changes in skin color;

  • increased or ongoing erection of the penis;

  • impotence, ejaculation problems, decreased amounts of semen, decrease in testicle size;

  • painful or difficult urination;

  • shortness of breath (even with mild exertion);

  • chest pain or pressure, pain spreading to your jaw or shoulder;

  • swelling in your ankles or feet, rapid weight gain;

  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

  • signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs;

  • high levels of calcium in the blood--stomach pain, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless; or

  • liver problems--upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Women receiving testosterone may develop male characteristics, which could be irreversible if treatment is continued. Call your doctor at once if you notice any of these signs of excess testosterone:

  • acne;

  • changes in menstrual periods;

  • male-pattern hair growth (such as on the chin or chest);

  • hoarse or deepened voice; or

  • enlarged clitoris.

Common side effects (in men or women) may include:

  • breast swelling;

  • headache, anxiety;

  • increased facial or body hair growth, male-pattern baldness;

  • increased or decreased interest in sex;

  • numbness or tingly feeling; or

  • pain or swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Uses for Testosterone Cypionate

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Male Hypogonadism

Management of congenital or acquired primary hypogonadism such as that resulting from orchiectomy or from testicular failure caused by cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.117 133 135 157 161 162 a

Management of congenital or acquired hypogonadotropic hypogonadism such as that resulting from idiopathic gonadotropin or gonadotropin-releasing hormone (luteinizing hormone-releasing hormone) deficiency or from pituitary-hypothalamic injury caused by tumors, trauma, or radiation.117 133 135 157 161 162 a Used in the treatment of hypogonadotropic hypogonadism only in patients uninterested in or unable to achieve fertility.f

Considered the androgen of choice for the treatment of androgen deficiency (e.g., hypogonadism) and AIDS wasting in HIV-infected men.126

May be used to stimulate puberty when the diagnosis is well established in carefully selected males with delayed puberty (designated an orphan drug by FDA for this use).a 162

Some experts (e.g., American College of Rheumatology) recommend that men who develop low serum testosterone concentrations (<300 ng/mL) while receiving long-term corticosteroid therapy receive testosterone replacement therapy in an attempt to treat hypogonadism and possibly reduce the risk of corticosteroid-induced osteoporosis†.122

Safety and efficacy of testosterone replacement therapy in men with late-onset hypogonadism (i.e., low testosterone concentrations related to aging) not established.133 175 Further study needed to elucidate the role of testosterone replacement therapy in treatment of this condition.176

Not indicated for the treatment of erectile dysfunction† in men with normal testosterone concentrations.158

Breast Cancer

Palliative treatment of androgen-responsive, advanced, inoperable, metastatic (skeletal) breast cancer in women who are 1–5 years postmenopausal and in premenopausal women who have benefited from oophorectomy.a 162

Poorly tolerated (see Virilization under Cautions); other hormonal agents (e.g., tamoxifen, anastrozole, letrozole, exemestane) currently are preferred for this use.d e

Misuse and Abuse

Has been misused and abused by athletes, bodybuilders, weight lifters, and others to enhance athletic performance or physique†.100 101 102 103 104 105 106 107 108 109 110 111 112 114 115 116 120

Medical and sports experts (e.g., International Olympic Committee) consider such use to be inappropriate and unacceptable because of known adverse effects and potential long-term sequelae and because such use by athletes is contrary to the rules and ethical principles of athletic competition.101 102 107 114 115 116

Testosterone Cypionate Dosage and Administration

General

  • Confirm diagnosis of hypogonadism by laboratory testing prior to initiation of therapy.133 175

  • Measure serum testosterone concentrations in the morning on at least 2 separate days.133 175 To confirm diagnosis, measurements must be consistently below the normal range.133 175 Serum testosterone concentrations may be low later in the day in men with or without hypogonadism; avoid measuring testosterone concentrations later in the day.175

Male Hypogonadism

  • Individualize dosage according to the condition being treated; the severity of symptoms; the patient’s age, gender, and history of prior androgenic therapy; and the specific testosterone preparation being used.a

  • Monitor every 3–4 months during the first year of testosterone replacement and periodically thereafter (e.g., every 4–6 months) for response and tolerance.123

Delayed Puberty

  • Prior to initiation of therapy, fully discuss the potential risk of therapy with the patient and his parents.a 162

  • Take into consideration the chronological and skeletal ages of the patient, both in determining the initial dosage and in adjusting the dosage.117 162 a

  • Perform radiographic examination of the hand and wrist at 6-month intervals to determine the rate of bone maturation and to assess the effect of therapy on the epiphyseal centers.117 162 a (See Pediatric Use under Cautions.)

Breast Cancer

  • Administer only under supervision of a qualified clinician experienced in the treatment of breast cancer.162 a

  • May occasionally appear to accelerate progression of the disease;162 a monitor patients closely.162

  • Discontinue the drug if hypercalcemia occurs, since this may indicate progression of metastases to the bone.162

Administration

Administer testosterone topically or intrabuccally.133 157 161 166

Administer testosterone cypionate and testosterone enanthate by deep IM injection;117 162 not for IV administration.117

IM Administration

Administer by deep IM injection into the upper outer quadrant of the gluteus maximus.117 162

Topical Administration

Gel

AndroGel: Apply gel topically once daily, preferably in the morning, to clean, dry, intact skin on the shoulders and upper arms and/or abdomen.166 Do not apply to the genitals.166

AndroGel unit-dose packet: Upon opening the unit-dose packet, squeeze the entire contents into the palm of the hand and immediately apply to the application site.135 Alternatively, squeeze a portion of the contents into the palm of the hand and immediately apply to application site; repeat procedure until entire contents of the packet applied.135

AndroGel metered-dose pump: Collect gel in the palm of the hand by pressing the pump firmly and fully; apply to application site.135 This can be done one pump actuation at a time or after completion of all pump actuations needed for the daily dose.135 Alternatively, apply the gel directly to application site (direct application prevents loss of gel during transfer to hand).135 Prime pump by depressing 3 times before using the pump for the first dose; discard gel so that household members or pets are not exposed to the gel (i.e., rinse down sink).135

Testim: Apply gel topically once daily, preferably in the morning, to clean, dry, intact skin on the shoulders and/or upper arms157 Do not apply to abdomen or genitals.157 Upon opening the unit-dose tube, squeeze the entire contents into the palm of the hand and immediately apply to the application site.157

Immediately wash hands with soap and water after application of the gel.157 166 170 171

Allow the application site to dry for a few minutes after application of gel.166 170 171 After the gel has dried, cover site with clothing (e.g., a shirt) to prevent transfer to another individual.157 166

Manufacturer of AndroGel recommends waiting ≥5–6 hours166 and the manufacturer of Testim recommends waiting ≥2 hours after application before showering or swimming.157 However, showering or swimming after the elapse of just 1 hour should have a minimal effect on the amount of testosterone gel absorbed if done very infrequently.135

Wash the application site(s) thoroughly with soap and water to remove any testosterone residue prior to situations in which skin-to-skin contact with other individuals is anticipated at the site of testosterone gel application.170 171 If unwashed or unclothed skin at the site of testosterone gel application comes in contact with the skin of another individual, wash the general area of contact with soap and water as soon as possible.157 166 170 171

Consider the possibility of secondary exposure to testosterone topical gel.157 166 170 171 (See Virilization in Children and Women from Secondary Exposure to Testosterone under Cautions.)

Transdermal System

Apply the transdermal system to clean, dry area of skin on the back, abdomen, upper arm, or thigh by firmly pressing the system with the adhesive side touching the skin.133 Do not apply to the scrotum or to oily, damaged, or irritated areas of the skin.133 134

To avoid burn-like blisters, do not apply systems over bony prominences or on a part of the body that may be subject to prolonged pressure during sleep or sitting (e.g., the deltoid region of the upper arm, the greater trochanter of the femur, the ischial tuberosity).133

Apply once daily at night (e.g., 10 p.m.).133 Leave transdermal system in place for 24 hours; after 24 hours, remove system and apply a new system.133 Apply system immediately after removal from its protective pouch and removal of the protective liner.133

If transdermal system becomes loose, smooth down by firmly rubbing a finger around the edges.133 If system inadvertently comes off before noon following application the previous evening, apply a new system until the next scheduled application that evening.133 If system inadvertently comes off later in the day, do not replace until the next scheduled application that evening.133 Do not reapply with tape.133

To minimize and/or prevent potential skin irritation, apply each transdermal system at a different site, with ≥1 week between applications to a particular site.133

Mild skin irritation may be ameliorated with topical OTC hydrocortisone cream after system removal; alternatively, apply a small amount of triamcinolone acetonide 0.1% cream to the skin under the drug reservoir (do not use ointment formulations because they may reduce testosterone absorption).133 143

Transdermal system does not need to be removed during sexual intercourse or while showering or bathing; however, avoid swimming, showering, or washing the administration site for at least 3 hours following application.133

Remove transdermal system before undergoing magnetic resonance imaging (MRI).133 (See Magnetic Resonance Imaging under Cautions.)

Intrabuccal Administration

Press the extended-release buccal (transmucosal) tablet against the gum above the upper left or right incisor twice daily (morning and evening) about 12 hours apart.161 These tablets will adhere to the gum and do not dissolve completely; do not chew or swallow.161 Dislodge and remove the tablet after 12 hours.161 Alternate application sites above the left and right upper incisors.161

Consult manufacturer’s patient information for instructions on proper intrabuccal administration and removal of the tablet.161

If the tablet fails to properly adhere to the gum or falls off within the first 8 hours, replace the old tablet with a new one.161 The new tablet may remain in place until the time of the next regularly scheduled dose (i.e., 12 hours after the original buccal tablet was administered).161 If the buccal tablet falls off after 8 hours but before 12 hours, replace the original tablet with one that can serve as the second dose for that day.161

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Available as testosterone; dosage expressed in terms of testosterone.133 135 157 161 Also available as testosterone enanthate or testosterone cypionate; dosage expressed in terms of the salts.117 162

AndroGel unit-dose packets contain 2.5 or 5 g of gel (25 or 50 mg of testosterone).135 Each depression of the metered-dose pump delivers 1.25 g of gel (12.5 mg of testosterone) after priming.135

Androderm 2 mg transdermal system contains 9.7 mg of testosterone for delivery of testosterone 2 mg/24 hours.133 Androderm 4 mg transdermal system contains 19.5 mg of testosterone for delivery of testosterone 4 mg/24 hours.133

Testim unit-dose tubes contain 5 g of gel (50 mg of testosterone).157

Pediatric Patients

Male Hypogonadism Delayed Puberty IM

Dosage regimens vary.117 162 a Some clinicians recommend that lower dosages be used initially, followed by gradual increases in dosage as puberty progresses; subsequently, the dosage may be decreased to maintenance levels.117 162 a Other clinicians state that higher dosages are required initially to induce pubertal changes and lower dosages can then be used for maintenance therapy after puberty.117 162 a

Usual dosage of testosterone enanthate: 50–200 mg every 2–4 weeks for a limited period of time (e.g., 4–6 months).a 162

Adults

Male Hypogonadism IM

Usual dosage: 50–400 mg of testosterone cypionate or testosterone enanthate every 2–4 weeks.117 162

Some clinicians recommend testosterone cypionate or testosterone enanthate dosage of 50–100 mg every 7–10 days or 100–150 mg every 2 weeks.f While dosage of 300 mg every 3 weeks also may be considered for convenience, such dosing is associated with wider testosterone fluctuations and generally is inadequate to ensure a consistent clinical response.123 Serum total testosterone concentrations generally should exceed lower limit of normal (in the range of 250–300 ng/dL) just before the next dose.123

Adult males with prepubertal onset of hypogonadism who are going through puberty for the first time with testosterone replacement: Initially, 50 mg every 3–4 weeks;f increase dosage gradually in subsequent months as tolerated up to full replacement within 1 year.123

Attainment of full virilization may require up to 3–4 years of IM testosterone replacement.123

Topical (Gel)

AndroGel and Testim: Apply 50 mg of testosterone (5 g of 1% gel) once daily, preferably in the morning; this dose delivers about 5 mg of testosterone systemically.135 157 Adjust dosage according to serum testosterone concentrations obtained at regular intervals after initiating daily application of AndroGel166 and approximately 14 days after initiating Testim.157

AndroGel: If serum testosterone concentrations are below the normal range or the clinical response is inadequate, the dosage can be increased initially to 75 mg of testosterone (7.5 g of 1% gel) and, if necessary, subsequently to 100 mg of testosterone (10 g of 1% gel).135 If serum testosterone concentrations exceed the normal range, the daily dosage may be decreased.166 If serum testosterone concentrations consistently exceed the normal range at a daily dosage of 50 mg of testosterone (5 g of 1% gel), discontinue application of the gel.166

Testim: If serum testosterone concentrations are below the normal range or the clinical response is inadequate, may increase dosage to 100 mg of testosterone (10 g of 1% gel).157

Topical (Transdermal System)

Usual initial dosage is 1 system delivering 4 mg/24 hours applied to the skin nightly.133

Adjust dosage according to morning serum testosterone concentrations approximately 2 weeks following initiation of therapy.133 Depending on requirements, increase dosage to 6 mg once daily (administered nightly as 1 system delivering 4 mg/24 hours plus 1 system delivering 2 mg/24 hours) or decrease dosage to 2 mg once daily (administered nightly as 1 system delivering 2 mg/24 hours).133

Switch patients currently maintained on a dosage of 2.5 mg/24 hours to 1 system delivering 2 mg/24 hours at next scheduled dose.133 Switch patients currently maintained on a dosage of 5 mg/24 hours to 1 system delivering 4 mg/24 hours at next scheduled dose.133 Switch patients currently maintained on a dosage of 7.5 mg/24 hours to 1 system delivering 4 mg/24 hours plus 1 system delivering 2 mg/24 hours at next scheduled dose.133

Approximately 2 weeks after switching therapy, measure patient's morning serum testosterone concentrations following system application the previous evening to ensure proper dosing.133

Intrabuccal

30 mg (1 extended-release transmucosal tablet) twice daily (morning and evening) about 12 hours apart.161 Serum testosterone concentration may be determined just prior to the morning dose at 4–12 weeks after initiation of intrabuccal therapy; if total serum testosterone concentration is excessive, discontinue intrabuccal therapy and consider alternative treatments.161

Breast Cancer IM

200–400 mg of testosterone cypionate or testosterone enanthate every 2–4 weeks.162 a

Special Populations

No special population dosage recommendations at this time.157 166

Testosterone Cypionate Description

Testosterone Cypionate Injection, for intramuscular injection, contains Testosterone Cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone.

Testosterone Cypionate 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 is androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17ß)-. Its molecular formula is C27H40O3, and the molecular weight 412.61.

The structural formula is represented below:

Testosterone Cypionate Injection is available in two strengths, 100 mg/mL and 200 mg/mL Testosterone Cypionate.

Each mL of the 100 mg/mL solution contains:
  Testosterone Cypionate 100 mg
  Benzyl benzoate 0.1 mL
  Cottonseed oil 736 mg
  Benzyl alcohol (as preservative) 9.45 mg
Each mL of the 200 mg/mL solution contains:
  Testosterone Cypionate 200 mg
  Benzyl benzoate 0.2 mL
  Cottonseed oil 560 mg
  Benzyl alcohol (as preservative) 9.45 mg

Testosterone Cypionate - 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 phosphorous, 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.

Indications and Usage for Testosterone Cypionate

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 Injection in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.

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 Injection.

Abuse of Testosterone and Monitoring of Serum Testosterone Concentrations

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 treatment may accelerate bone maturation without producing compensatory gain in linear growth. This adverse effect may result in compromised adult stature. The younger the child the greater the risk of compromising final mature height.

This drug has not been shown to be safe and effective for the enhancement of athletic performance. Because of the potential risk of serious adverse health effects, this drug should not be used for such purpose.

PRINCIPAL DISPLAY PANEL - 200 mg/mL Vial Carton

NDC 0409-6562-01

One 1 mL Vial
Single-dose

Testosterone
Cypionate
Injection, USP

200 mg/mL
CIII

For intramuscular
use only

Rx only

Hospira

Testosterone Cypionate 
Testosterone Cypionate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0409-6557
Route of Administration INTRAMUSCULAR DEA Schedule CIII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Testosterone Cypionate (TESTOSTERONE) Testosterone Cypionate 100 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL BENZOATE 0.1 mL  in 1 mL
COTTONSEED OIL 736 mg  in 1 mL
BENZYL ALCOHOL 9.45 mg  in 1 mL
Packaging
# Item Code Package Description
1 NDC:0409-6557-01 1 VIAL in 1 CARTON
1 10 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085635 08/01/2016
Testosterone Cypionate 
Testosterone Cypionate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0409-6562
Route of Administration INTRAMUSCULAR DEA Schedule CIII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Testosterone Cypionate (TESTOSTERONE) Testosterone Cypionate 200 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL BENZOATE 0.2 mL  in 1 mL
COTTONSEED OIL 560 mg  in 1 mL
BENZYL ALCOHOL 9.45 mg  in 1 mL
Packaging
# Item Code Package Description
1 NDC:0409-6562-01 1 VIAL in 1 CARTON
1 1 mL in 1 VIAL
2 NDC:0409-6562-20 1 VIAL in 1 CARTON
2 10 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085635 08/01/2016
Labeler - Hospira, Inc. (141588017)
Establishment
Name Address ID/FEI Operations
Pharmacia and Upjohn Company LLC 618054084 ANALYSIS(0409-6557, 0409-6562), API MANUFACTURE(0409-6557, 0409-6562), LABEL(0409-6557, 0409-6562), MANUFACTURE(0409-6557, 0409-6562), PACK(0409-6557, 0409-6562)
Revised: 03/2017   Hospira, Inc.
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