Brand — testosterone cypionate, approved under an ANDA
Depo-Testosterone
The best-known testosterone brand in the United States is an approved generic-pathway product, ANDA 085635. Its two strengths are not one formula diluted: per milligram of drug, the 100 mg/mL vial carries 2.6 times the cottonseed oil.
- Molecule
- testosterone cypionate
- Manufacturer
- Pharmacia & Upjohn Company LLC
- Products under this name
- 1
- Last reviewed
Why the brand you recognise is not the innovator product
Depo-Testosterone is the name most people in the United States attach to injectable testosterone, and the assumption that follows — that it is the original, brand-name, NDA-approved version and the vials with a generic label are copies of it — does not survive reading its own approval block. The SPL records marketing category ANDA and application ANDA 085635. It is an approved abbreviated application, the same regulatory pathway as the unbranded cypionate vials sold next to it, and the products that hold new drug applications for this hormone are the newer ones: XYOSTED under NDA 209863, JATENZO under NDA 206089, ANDROGEL under NDA 021015 and NDA 022309, AVEED under NDA 022219. This page prints application numbers next to every dose it quotes, so it prints that one accurately rather than assuming the brand implies the pathway.
What the brand does have that the generics read for this page do not is a second strength. DEPO-Testosterone is supplied at 100 mg/mL and at 200 mg/mL, and the two are not the same solution at different dilutions. Per millilitre the 100 mg/mL contains 736 mg of cottonseed oil and 0.1 mL of benzyl benzoate; the 200 mg/mL contains 560 mg and 0.2 mL. Work that back to the drug and the weaker vial delivers 736 mg of oil for every 100 mg of testosterone against the stronger vial's 280 mg — 2.6 times as much. For a man with a cottonseed sensitivity, or one injecting a large volume into a gluteal muscle every fortnight, those are different products in the same carton family.
The third thing the brand name conceals is the age of the document. This is the only US testosterone label still written in the pre-PLR format: DESCRIPTION, CLINICAL PHARMACOLOGY, INDICATIONS AND USAGE, WARNINGS, with no numbered sections, no Highlights, no Recent Major Changes table and no boxed-warning section to remove things from. Every other product on this site quotes a section 5.4; this label has no sections at all. A reader trying to check whether FDA changed something here in 2025, the way it did on the oral and subcutaneous products, has nothing to look it up in.
What is true of Depo-Testosterone and not of testosterone cypionate
Each row is something a reader would reasonably assume belongs to the molecule, and does not. These are the facts that change when the brand name on the carton changes, while the drug inside it does not.
| Attribute | Depo-Testosterone | Elsewhere, same molecule |
|---|---|---|
| The regulatory pathway the brand holdsThe inference that a brand name means an innovator product, and that the unbranded vial beside it is a copy of this one, does not hold here. Both are ANDAs. Anyone using "is it the brand?" as a proxy for "which application was it approved under?" gets the wrong answer for the most-prescribed injectable testosterone in the United States. | Marketing category ANDA, application ANDA 085635. The approval block on the SPL reads `displayName="ANDA"`, so the best-known testosterone brand in the country is an approved abbreviated application. | Every other approved testosterone brand this site covers holds a new drug application: XYOSTED NDA 209863, JATENZO NDA 206089, ANDROGEL NDA 021015 and NDA 022309, AVEED NDA 022219, NATESTO NDA 205488, TESTIM NDA 021454. |
| How much oil comes with the drugSwitching a patient from the 100 mg/mL vial to the 200 mg/mL one at the same milligram dose more than halves his cottonseed oil and doubles his benzyl benzoate, while halving the injected volume. For a cottonseed sensitivity, an injection-site reaction or a large fortnightly volume that is a change of medicine, and no pharmacy system flags it as one. | Two strengths with two formulas. Per mL the 100 mg/mL carries 736 mg of cottonseed oil and 0.1 mL of benzyl benzoate; the 200 mg/mL carries 560 mg and 0.2 mL. Per 100 mg of testosterone that is 736 mg of oil against 280 mg. | The approved generic cypionate SPLs read for this page — Hikma ANDA 091244, Alvogen ANDA 207742 and the BPI/Ajenat ANDA 219478 listings — each supply one strength only, 200 mg/mL, with the same 560 mg of cottonseed oil per mL as the brand's stronger vial. |
| What format the label is written inEvery cross-reference a reader is given elsewhere — "see section 5.4", "check Recent Major Changes" — fails on this label. There is nowhere on it to look up whether the 2025 testosterone labelling changes touched this product, and the blood-pressure paragraph sits unnumbered in the middle of WARNINGS rather than in a section with a name. | The pre-PLR format: DESCRIPTION, CLINICAL PHARMACOLOGY, INDICATIONS AND USAGE, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION. No numbered sections, no Highlights, no Recent Major Changes table, and no boxed-warning section — not one that was removed, one that has never existed on this document. | XYOSTED, JATENZO and both AndroGels are PLR labels with numbered sections, Highlights and a Recent Major Changes table that records exactly what FDA changed and when — including the boxed warnings removed from XYOSTED in 03/2025 and from JATENZO in 2025. |
| The interval, and how wide it isWeekly dosing — what most men on cypionate actually do — is not on this label. 14 days is the shortest interval it names, and the only US testosterone product labelled weekly is a sealed subcutaneous autoinjector of a different ester. That gap between label and practice is real, and this page names which side of it any given schedule is on. | One sentence: "For replacement in the hypogonadal male, 50–400 mg should be administered every two to four weeks." An eight-fold dose range crossed with a two-fold interval range, with no starting dose, no titration table and no target concentration named. | XYOSTED is fixed at 75 mg subcutaneously once every 7 days, titrated in 25 mg steps against a trough of 350 to 650 ng/dL measured at 6 weeks. AVEED is 750 mg intramuscularly at week 0, week 4, then every 10 weeks. JATENZO is 237 mg orally twice a day against a level drawn 6 hours after the morning dose. |
| Which esters may be swapped for whichFour products of one hormone, four different non-substitution sentences, each scoped to a different thing — one ester pair, one topical class, one oral class. There is no general rule, and reading one of these sentences as "testosterone products are not interchangeable" over-reads all of them. | The label names one prohibition and it is specific: "Testosterone cypionate should not be used interchangeably with testosterone propionate because of differences in duration of action." It says nothing at all about enanthate. | The PLR labels each forbid substitution inside their own dosage class instead — "The application site and dose of AndroGel 1% are not substitutable with other topical testosterone products", "KYZATREX® is not substitutable with other oral testosterone undecanoate products", "TLANDO is not substitutable with other oral testosterone undecanoate products". |
| The age below which nothing is establishedA 14-year-old is inside the age band this label has something to say about and outside every other testosterone label's. The boundary moves by six years depending on which product is in the room, and it moves because of what was studied, not because of anything about the hormone. | "Safety and effectiveness in pediatric patients below the age of 12 years have not been established." The label then goes on to describe androgen therapy in healthy males with delayed puberty, with bone age monitored every 6 months. | XYOSTED: "Safety and effectiveness of XYOSTED in pediatric patients less than 18 years old have not been established." JATENZO: the same, less than 18. AndroGel 1% and 1.62%: safety and efficacy in males less than 18 years old have not been established, stated as a Limitation of Use in section 1. |
| Whether a half-life figure existsThe eight-day figure quoted everywhere as "testosterone's half-life" is one ester's number from one label, and there is no labelled counterpart to compare it with. Any table that sets an eight-day cypionate against a specific enanthate half-life is sourcing the second half from somewhere other than an FDA label. | Stated, and unusually precisely for a label of this vintage: "The half-life of testosterone cypionate when injected intramuscularly is approximately eight days." | No enanthate label states an ester half-life. The Hikma testosterone enanthate SPL (ANDA 091120) offers only "There are considerable variations of the half-life of testosterone as reported in the literature, ranging from 10 to 100 minutes", which is free testosterone rather than the ester, and XYOSTED's PK section gives no half-life at all. |
| Whether there is a boxed warningTwo intramuscular testosterone oils, one observed for half an hour in a clinic under a restricted programme and one drawn at a kitchen table. The presence of a box is a property of the oil volume, the ester and the delivery system, never of the hormone. | There is not, and there never has been. The document has no boxed-warning section. The blood-pressure language is an unnumbered paragraph inside WARNINGS, and the strongest framing on the page is "Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men." | AVEED — testosterone undecanoate, also an intramuscular oil depot — opens with "WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS", requires 30 minutes of observation in the healthcare setting after every injection, and is available only through a REMS. Both AndroGels open with a boxed warning about secondary exposure to children. |
DEPO-Testosterone Injection
- Dosage form
- Injection, solution — in cottonseed oil, CIII
- Route
- Intramuscular only, deep in the gluteal muscle
- Marketing category
- ANDA — ANDA085635
- Label read
- SPL version 26, effective August 21, 2026
What this product is approved to treat
- —DEPO-Testosterone Injection 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 LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.
- —Limitation, in the label's own words: "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."
The labelled ladder
| When | Dose | What the label attaches to this step |
|---|---|---|
| Before the first dose | None | Not a dose but a precondition, and the first sentence of the section: "Prior to initiating DEPO-Testosterone (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." |
| Every 14 to 28 days | 50–400 mg intramuscularly | The whole of the replacement regimen, in one sentence: "For replacement in the hypogonadal male, 50–400 mg should be administered every two to four weeks." There is no starting dose distinct from a maintenance dose, no escalation and no titration table. "The suggested dosage for DEPO-Testosterone 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." |
| Every dose, without exception | Deep intramuscular, gluteal | "DEPO-Testosterone Injection is for intramuscular use only. It should not be given intravenously. Intramuscular injections should be given deep in the gluteal muscle." The Precautions repeat it: "Testosterone cypionate is not for intravenous use." No subcutaneous administration is described anywhere on this label. |
| Inducing puberty (a separate use of the same vial) | Not specified — the label declines to choose | "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." That is a report of disagreement between experts, not a schedule, and this page does not turn it into one. |
| Before drawing from a cold vial | Unchanged | "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." |
Ceiling. The label names no maximum dose. It names a range — "For replacement in the hypogonadal male, 50–400 mg should be administered every two to four weeks." — and the phrase "maximum recommended dosage", which appears on the newer testosterone labels and on the minoxidil tablet label, appears nowhere in this document. Taken at its bounds the sentence authorises anything from 50 mg every four weeks to 400 mg every two, a sixteen-fold spread of weekly exposure, and the only guidance for choosing inside it is "Dosage is adjusted according to the patient’s response and the appearance of adverse reactions." Overdosage says only: "There have been no reports of acute overdosage with the androgens."
How it is supplied
| Presentation | Total strength | Concentration | Delivers |
|---|---|---|---|
| Multiple-dose vial, 10 mL — NDC 0009-0347-02 | 1000 mg per vial | 100 mg/mL, in 736 mg cottonseed oil, 0.1 mL benzyl benzoate and 9.45 mg benzyl alcohol per mL — 736 mg of oil per 100 mg of drug | Multiple-dose. The preservative is benzyl alcohol, and the label warns that it "has been associated with serious adverse events, including the “gasping syndrome”, and death in pediatric patients". |
| Multiple-dose vial, 10 mL — NDC 0009-0417-02 | 2000 mg per vial | 200 mg/mL, in 560 mg cottonseed oil, 0.2 mL benzyl benzoate and 9.45 mg benzyl alcohol per mL — 280 mg of oil per 100 mg of drug | Multiple-dose. The preservative is benzyl alcohol, and the label warns that it "has been associated with serious adverse events, including the “gasping syndrome”, and death in pediatric patients". |
| Single-dose vial, 1 mL — NDC 0009-0417-01 | 200 mg per vial | 200 mg/mL, in 560 mg cottonseed oil, 0.2 mL benzyl benzoate and 9.45 mg benzyl alcohol per mL — 280 mg of oil per 100 mg of drug | Labelled single-dose: anything left after one injection is discarded by the label, not by choice. |
Administration, as the label words it
- —"DEPO-Testosterone Injection is for intramuscular use only. It should not be given intravenously. Intramuscular injections should be given deep in the gluteal muscle."
- —Pharmacokinetics: "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." And the one PK number this label states: "The half-life of testosterone cypionate when injected intramuscularly is approximately eight days."
- —Precautions: "Testosterone cypionate should not be used interchangeably with testosterone propionate because of differences in duration of action." A named non-substitution, between two esters of the same hormone.
- —Warnings, and the reason this page exists in the shape it does: "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."
- —Warnings: "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."
- —Laboratory tests: "Hemoglobin and hematocrit levels (to detect polycythemia) should be checked periodically in patients receiving long-term androgen administration." And: "Serum cholesterol may increase during androgen therapy."
- —Contraindications include "Males with known or suspected carcinoma of the prostate gland", "Males with carcinoma of the breast", "Women who are pregnant" and "Patients with serious cardiac, hepatic or renal disease".
- —Warnings: "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."
Storage
- Vial, sealed or in use
- "Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light."
- Until the expiration date on the vial
- Vial that has been too cold
- Crystals may form. "Warming and shaking the vial should redissolve any crystals that may have formed during storage at temperatures lower than recommended."
- Inspect visually for particulate matter and discoloration before every dose
- The 1 mL, 200 mg/mL vial
- Labelled single-dose. Unlike the two 10 mL presentations it carries no in-use period, because the label does not contemplate a second entry.
- Discard after one injection
Children and adolescents
"Safety and effectiveness in pediatric patients below the age of 12 years have not been established." Twelve, not eighteen — and the Warnings add that 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." Bone age of the wrist and hand should be assessed every 6 months in healthy males treated for delayed puberty.
This statement belongs to DEPO-Testosterone Injection. It is not a statement about testosterone cypionate, and another brand of the same molecule may say the opposite.
The same molecule under other brand names
Everything below is testosterone cypionate. None of it is Depo-Testosterone, and a dose from one column carried into another is not a smaller or larger version of the same instruction — it is a different product’s schedule.
| Brand | Form | Approved for | Ladder | Maximum |
|---|---|---|---|---|
| Testosterone Cypionate Injection, USP (Hikma) | Intramuscular oil solution, 200 mg/mL only — ANDA 091244 | Replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone; primary hypogonadism and hypogonadotropic hypogonadism, with the same age-related-hypogonadism limitation | 50–400 mg every two to four weeks, deep intramuscular — the identical sentence | No maximum stated. One strength only, 200 mg/mL in 560 mg cottonseed oil per mL; no 100 mg/mL presentation |
| Testosterone Cypionate Injection, USP (Alvogen) | Intramuscular oil solution, 200 mg/mL only — ANDA 207742 | The same two hypogonadism indications, on the same pre-PLR template, with the same blood-pressure and venous-thromboembolism warnings | 50–400 mg every two to four weeks, deep intramuscular | No maximum stated; one strength only |
Switching between products
The only substitution this label rules on
Testosterone cypionate should not be used interchangeably with testosterone propionate because of differences in duration of action.
DEPO-Testosterone
The route is not negotiable, and the label says so twice
DEPO-Testosterone Injection is for intramuscular use only. It should not be given intravenously. Intramuscular injections should be given deep in the gluteal muscle.
DEPO-Testosterone
Blood pressure, in the words every testosterone vial label uses
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.
DEPO-Testosterone
What this page does not tell you
- Price — list, cash or copay
- No price appears anywhere on this page, and no price is emitted in its structured data. Testosterone cypionate is dispensed as a brand and as several generics, in 1 mL and 10 mL vials at two strengths, through retail pharmacies, mail order, compounding pharmacies and clinic dispensing, at rates that differ by an order of magnitude between those channels. Our TRT cost calculator works from a dated acquisition-cost snapshot with its as-of date attached, which is the only form in which we will state a figure, and this page links to it rather than printing one.
- A weekly dose
- This label does not have one. It states 50 to 400 mg every two to four weeks, and dividing a fortnightly or monthly figure by the number of weeks in it would produce a weekly dose the document never authorised — while looking exactly like a quotation. Weekly injection of cypionate is widespread clinical practice and there is a real pharmacological argument for it given the eight-day half-life, but the only US testosterone product labelled weekly is XYOSTED, a sealed subcutaneous autoinjector of a different ester. Our injection schedule planner labels each interval as on-label, XYOSTED-only or not labelled rather than silently accepting any of them.
- A target blood level
- The label names none. It directs confirming hypogonadism with two morning measurements below the normal range before starting, and then adjusting "according to the patient’s response and the appearance of adverse reactions" — with no target concentration, no trough window and no timing for a follow-up draw. Every trough figure attached to cypionate in practice comes from somewhere other than this document. The newer products do state windows in their own labels: XYOSTED titrates to a trough of 350 to 650 ng/dL and JATENZO to 425 to 970 ng/dL six hours post-dose, and neither range was derived for, or validated on, an intramuscular depot.
- A conversion to any other testosterone product
- There is no labelled equivalence between testosterone cypionate and testosterone enanthate, undecanoate, a topical gel or a nasal gel, in either direction, and this page does not construct one. The esters differ in duration of action — which is the entire reason the label forbids swapping cypionate for propionate — and the topical and oral products deliver a fraction of the milligrams for a comparable serum effect. A table with one product down an axis and another across the top would be an equivalence table however it were captioned.
Frequently asked questions
- Is Depo-Testosterone a brand-name drug or a generic?
- Both descriptions are partly right, which is why the question keeps being asked. Depo-Testosterone is a registered brand name, sold by Pharmacia & Upjohn, and it is approved under an abbreviated new drug application — marketing category ANDA, application ANDA 085635, the same pathway as the unbranded cypionate vials beside it. The newer testosterone products hold full new drug applications: XYOSTED under NDA 209863, JATENZO under NDA 206089, AndroGel under NDA 021015 and NDA 022309.
- What is the difference between the 100 mg/mL and 200 mg/mL vials?
- More than the concentration. Per millilitre the 100 mg/mL contains 736 mg of cottonseed oil, 0.1 mL of benzyl benzoate and 9.45 mg of benzyl alcohol; the 200 mg/mL contains 560 mg, 0.2 mL and the same 9.45 mg. Per 100 mg of testosterone that works out at 736 mg of oil against 280 mg — 2.6 times as much in the weaker vial. The 100 mg/mL comes only as a 10 mL multiple-dose vial; the 200 mg/mL comes as a 10 mL multiple-dose vial and a 1 mL single-dose vial.
- What dose of Depo-Testosterone does the label actually allow?
- One sentence covers it: "For replacement in the hypogonadal male, 50–400 mg should be administered every two to four weeks." That is the whole regimen — no starting dose, no titration schedule, no maximum and no target level. Taken at its bounds it authorises anything from 50 mg every 28 days to 400 mg every 14, a sixteen-fold range of weekly exposure, and the only guidance for choosing inside it is that "Dosage is adjusted according to the patient’s response and the appearance of adverse reactions."
- Can Depo-Testosterone be injected subcutaneously or weekly?
- Neither is on this label. It states "DEPO-Testosterone Injection is for intramuscular use only. It should not be given intravenously. Intramuscular injections should be given deep in the gluteal muscle", and the shortest interval it names is two weeks. Both weekly dosing and subcutaneous injection of cypionate are common clinical practice, and there is a pharmacological case for weekly given the eight-day half-life — but the only US testosterone product labelled weekly and subcutaneous is XYOSTED, which is enanthate in a sealed autoinjector, abdomen only.
- Does Depo-Testosterone have a blood pressure warning?
- Yes, in the same words every testosterone vial label uses: "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." What it does not have, and has never had, is a boxed warning — the document predates the format and has no boxed-warning section. It also gives no ambulatory blood pressure figure of its own, unlike JATENZO (+4.9/2.5 mm Hg at 4 months) and XYOSTED (+3.9/1.5 mm Hg at 12 weeks).
- What is the half-life of testosterone cypionate?
- The label states it directly: "The half-life of testosterone cypionate when injected intramuscularly is approximately eight days." That figure is why the same document says esters in oil "can be given at intervals of two to four weeks". It is worth knowing that no enanthate label states an ester half-life at all — the Hikma enanthate SPL gives only free testosterone's 10 to 100 minutes, and XYOSTED's pharmacokinetics section gives none — so any side-by-side of cypionate and enanthate half-lives is taking the second number from outside the labels.
- Why is Depo-Testosterone in cottonseed oil?
- Because testosterone cypionate is "insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils", so it has to be carried in one. The vehicle is a product decision rather than a molecule one, and it differs across the class: cypionate is in cottonseed oil with benzyl benzoate, enanthate is in sesame oil (with chlorobutanol in the vial, preservative-free in XYOSTED), and AVEED is castor oil with benzyl benzoate. A sesame allergy and a cottonseed sensitivity rule out different products, and the oil is listed in Contraindications as a hypersensitivity route on the labels that use the PLR format.
- Is it approved for low testosterone from age?
- No, and the label says so in the indications section: "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." Every current testosterone label carries some version of that limitation. It is worth noting the direction of travel: JATENZO used to go further and list age-related hypogonadism as a contraindication, and its Recent Major Changes table records that contraindication being removed in 2025 and replaced by the same limitation-of-use wording.
Sources
- [1]FDA label — DEPO-Testosterone (testosterone cypionate) injection, solution, Pharmacia & Upjohn Company LLC. DailyMed SPL version 26, effective 2026-08-21, marketing category ANDA, application ANDA085635. Label revised September 2025 (LAB-0245-17.0)
- [2]FDA label — DEPO-Testosterone (testosterone cypionate) injection, solution, Pharmacia & Upjohn Company LLC, parallel NDC listing. DailyMed SPL version 16, effective 2025-07-14, same ANDA085635. Identical text; differs only in the NDC family (0009-0085 and 0009-0086 rather than 0009-0347 and 0009-0417)
- [3]FDA label — Testosterone Cypionate Injection, USP 200 mg/mL, Hikma Pharmaceuticals USA Inc. DailyMed SPL version 3, effective 2025-06-01, marketing category ANDA, application ANDA091244 — cited for the single-strength comparison, the 560 mg cottonseed oil per mL and the identical dosing sentence
- [4]FDA label — Testosterone Cypionate Injection, Alvogen Inc. DailyMed SPL version 5, effective 2026-08-19, marketing category ANDA, application ANDA207742 — cited for the sibling row, the single-strength comparison and the identical 560 mg cottonseed oil per mL
- [5]FDA label — Testosterone Enanthate Injection, USP 200 mg/mL, Hikma Pharmaceuticals USA Inc. DailyMed SPL version 10, effective 2026-05-08, marketing category ANDA, application ANDA091120 — cited for the sesame oil vehicle and for the absence of any ester half-life figure
- [6]FDA label — AVEED (testosterone undecanoate) injection, Endo USA, Inc. DailyMed SPL version 45, effective 2025-07-15, marketing category NDA, application NDA022219 — cited for the POME and anaphylaxis boxed warning, the REMS and the 750 mg every-10-weeks schedule
Next steps
- Testosterone cypionate: the compound reference
- TRT cost calculator — vials, doses and what is left in them
- Injection schedule planner — which intervals are labelled
- Xyosted — the one weekly, subcutaneous testosterone
- Testosterone ester comparison chart
- Testosterone dosage chart
Other brands
- AndroGelA 1% gel dosed 50 to 100 mg and a 1.62% gel dosed 20.25 to 81 mg, under separate applications, with pumps that look alike and deliver different amounts.
- XyostedTestosterone enanthate in a sealed single-dose autoinjector, 75 mg once weekly into the abdomen, titrated in 25 mg steps against a trough.
- JatenzoOral testosterone undecanoate in three capsule strengths, taken with food twice daily and adjusted on a level drawn six hours after the morning dose.
- OzempicA weekly injection capped at 2 mg and a daily tablet capped at 9 mg, sold under the same brand name and described in two different labels.
- WegovyA once-weekly injection and a once-daily 25 mg tablet sharing one label, one boxed warning and almost nothing else.
- MounjaroTirzepatide for type 2 diabetes and cardiovascular risk, with a conditional ladder, two maximum doses and no named maintenance dose.
Educational reference, not medical advice. Testosterone cypionate is a Schedule III controlled substance and a prescription-only medicine, contraindicated in pregnancy and in men with breast or suspected prostate carcinoma. This page reports what the FDA label states; it does not recommend a dose, an interval or a route.