NDC 69097-802 Testosterone Cypionate

Testosterone Cypionate

NDC Product Code 69097-802

NDC CODE: 69097-802

Proprietary Name: Testosterone Cypionate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Testosterone Cypionate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used in men who do not make enough of a natural substance called testosterone. In males, testosterone is responsible for many normal functions, including growth and development of the genitals, muscles, and bones. It also helps cause normal sexual development (puberty) in boys. Testosterone belongs to a class of drugs known as androgens. It works by affecting many body systems so that the body can develop and function normally. Testosterone may also be used in certain adolescent boys to cause puberty in those with delayed puberty. It may also be used to treat certain types of breast cancer in women.

NDC Code Structure

NDC 69097-802-32

Package Description: 1 VIAL, GLASS in 1 CARTON > 1 mL in 1 VIAL, GLASS

NDC 69097-802-37

Package Description: 1 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS

NDC Product Information

Testosterone Cypionate with NDC 69097-802 is a a human prescription drug product labeled by Cipla Usa Inc.. The generic name of Testosterone Cypionate is testosterone cypionate. The product's dosage form is injection, solution and is administered via intramuscular form.

Labeler Name: Cipla Usa Inc.

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

DEA Schedule: Schedule III (CIII) Substances What is the Drug Enforcement Administration (DEA) CIII Schedule?
The controlled substances in the CIII schedule have an abuse potential and dependence liability less than those in schedules CI and CII, and have an accepted medical use in the United States. Schedule CIII controlled substances include preparations containing limited quantities of certain narcotic drugs, and other nonnarcotic drugs such as: derivatives of barbituric acid, except those that are listed in another schedule, glutethimide (Doriden), methyprylon (Noludar), nalorphine, benzphetamine, chlorphentermine, clortermine, and phendimetrazine.

Testosterone Cypionate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.


Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intramuscular - Administration within a muscle.
  • Intramuscular - Administration within a muscle.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Androgen - [EPC] (Established Pharmacologic Class)
  • Androgen Receptor Agonists - [MoA] (Mechanism of Action)
  • Androstanes - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cipla Usa Inc.
Labeler Code: 69097
FDA Application Number: ANDA091244 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-26-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Testosterone Cypionate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index


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 C27H40O3, 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, USP200 mgBenzyl Benzoate, USP0.2 mLCottonseed Oil, USP560 mgBenzyl Alcohol, USP (as preservative)9.45 mg

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.


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

  • 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.


  • Known hypersensitivity to the drugMales with carcinoma of the breastMales with known or suspected carcinoma of the prostate glandWomen who are pregnant (see PRECAUTIONS, Pregnancy) Patients with serious cardiac, hepatic or renal disease (see 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-a alkyl-androgens) has been associatedwith 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 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.


Patients with benign prostatic hypertrophy may develop acute urethral obstruction. Priapism or excessive sexual
stimulation may develop. Oligospermia may occur after prolonged administration or excessive dosage. If any of these
effects appear, the androgen should be stopped and if restarted, a lower dosage should be utilized.Testosterone cypionate should not be used interchangeably with testosterone propionate because of differences in
duration of action.Testosterone cypionate is not for intravenous use.

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.

Laboratory Tests

Hemoglobin and hematocrit levels (to detect polycythemia) should be checked periodically in patients receiving long-term
androgen administration.Serum cholesterol may increase during androgen therapy.

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 Interferences

Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum
levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however,
and there is no clinical evidence of thyroid dysfunction.


Animal dataTestosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant
induced cervical-uterine tumors in mice, which metastasized in some cases. There is suggestive
evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma.
Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically
induced carcinomas of the liver in rats.Human dataThere are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high
doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases.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.

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.

Nursing Mothers

Testosterone cypionate injection is not recommended for use in nursing mothers.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

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 West-Ward Pharmaceuticals Corp. at 1-877-233-2001 or FDA
at 1-800-FDA-1088 or www.fda.gov/medwatch.

Controlled Substance

  • Testosterone Cypionate Injection contains testosterone, a Schedule III controlled substance in the Controlled
  • Substances Act.AbuseDrug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice.Abuse-Related Adverse Reactions
  • Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include
  • Cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident,
  • Hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis,
  • Delusions, hallucinations, hostility and aggression.The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania,
  • Irritability, dyslipidemias, testicular atrophy, subfertility, and infertility.The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice,
  • Clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities.The following adverse reactions have been reported in male and female adolescents: premature closure of bony
  • Epiphyses with termination of growth, and precocious puberty.Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other
  • Agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Dependence Behaviors Associated with AddictionContinued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors:Taking greater dosages than prescribedContinued drug use despite medical and social problems due to drug useSpending significant time to obtain the drug when supplies of the drug are interruptedGiving a higher priority to drug use than other obligations Having difficulty in discontinuing the drug despite desires and attempts to do soExperiencing withdrawal symptoms upon abrupt discontinuation of usePhysical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose
  • Reduction of a drug. Individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms
  • Lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness,
  • Irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism.Drug dependence in individuals using approved doses of testosterone for approved indications has not been
  • Documented.


There have been no reports of acute overdosage with the androgens.

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.

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, Cartons of 1 vial                                      NDC 69097-802-32
10 mL Multiple Dose Vials, Cartons of 1 vial           NDC 69097-802-37Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Protect from light.Manufactured by:HIKMA FARMACÊUTICA (PORTUGAL), S.A.
Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGALDistributed by:Cipla USA, Inc.1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323Revised: December 2018

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