Prescription medicine
Testosterone Brand names: Jatenzo, Xyosted, Kyzatrex, Azmiro, Vogelxo; first approved as Delatestryl
Testosterone (Jatenzo) is a prescription medicine with an FDA approval on record since 1953. FDA's NDC Directory lists it from 33 generic labelers, and pharmacies paid $11.39 per mL (Testosterone cyp 200 mg/mL) in the October 7, 2026 NADAC survey.
- Generic listed
- DEA Schedule III
Check it at the source: the testosterone FDA label on DailyMed (effective July 25, 2025, Azurity Pharmaceuticals, Inc.); the NDA 9165 record on Drugs@FDA; every testosterone label on DailyMed.
Highlights of the record
FDA label of July 25, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAZMIRO is indicated for testosterone replacement therapy in males in conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome;
Forms and strengths
- 12.5 mg
- 50 mg
- 75 mg
- 150 mg
- 158 mg
- 198 mg
- 200 mg
- 237 mg
- 1.62 mg/g
- 5.5 mg/.122g
- 10 mg/g
- 16.2 mg/g
Injection (solution); gel; injection; gel (metered); solution.
On the market
- Earliest approval on file
- December 24, 1953 Delatestryl, Endo Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 50 first July 13, 1972; 31 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 40 of which 33 under generic applications, 8 under brand applications, repackagers included
- Last listed patent
- April 12, 2039 Jatenzo capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $11.39 per mL Testosterone cyp 200 mg/mL
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 70 since 2013 1 Class I among all firms' recalls; latest January 26, 2026; 150 more by firms not listed as its makers
- FAERS reports
- 34,691 through July 30, 2026
What is testosterone used for?
From the label: indications and usageAZMIRO is indicated for testosterone replacement therapy in males in conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchiectomy, Klinefelter’s syndrome, or toxic damage from alcohol or heavy metals, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone (FSH), luteinizing hormone (LH)) above the normal range [ see Dosage and Administration ( 2.2 ) ]. […]
Conditions named in the indications of testosterone's FDA labels, with every medicine labeled for each:
From other testosterone labelsBreast cancer: This treatment has also been used in premenopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone-responsive tumor.
FDA pharmacologic class: Androgen.
Source: FDA drug label (AZMIRO), Azurity Pharmaceuticals, Inc., effective July 25, 2025 (SPL set 235b5625-570d-3fba-e063-6394a90aa2d1), via openFDA; the full label on DailyMed
Is there a generic for testosterone (Jatenzo)?
The FDA approved the first generic testosterone on July 13, 1972. 50 generic applications are approved; 31 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists testosterone from 33 labelers under a generic (ANDA) application and from 8 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 11 patents for Jatenzo capsules: the compound patent runs to April 12, 2030, and the last listed entry to April 12, 2039; a patent listed only for Tlando capsules runs to April 28, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1953 earliest approval on file
- 1972 first generic approved
- 2039 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for testosterone (Jatenzo)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $11.39 per mL (Testosterone cyp 200 mg/mL), down 5% from $12.02 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Testosterone cyp 200 mg/mL (generic)
- Depo-testosterone 1,000 mg/10 mL (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Testosteron enan 1,000 mg/5 mL | Generic | $14.48 per mL | n/a | +4% |
| Testosterone 1% (25 mg/2.5 g) pk | Generic | $1.20 per gram | n/a | -32% |
| Testosterone 1% (50 mg/5 g) pk | Generic | $0.406 per gram | n/a | -26% |
| Testosterone 1.62% (2.5 g) packet | Generic | $1.82 per gram | n/a | -18% |
| Testosterone 1.62% gel pump | Generic | $0.467 per gram | n/a | +5% |
| Testosterone 1.62%(1.25 g) packet | Generic | $3.65 per gram | n/a | -6% |
| Testosterone 12.5 mg/1.25 gram | Generic | $0.826 per gram | n/a | -18% |
| Testosterone 30 mg/1.5 mL pump | Generic | $0.508 per mL | n/a | -20% |
| Testosterone 50 mg/5 gram gel | Generic | $0.737 per gram | n/a | -7% |
| Testosterone 50 mg/5 gram packet | Generic | $0.406 per gram | n/a | -26% |
| Testosterone cyp 1,000 mg/10 mL | Generic | $4.53 per mL | n/a | -15% |
| Testosterone cyp 2,000 mg/10 mL | Generic | $3.58 per mL | n/a | +2% |
| Testosterone cyp 200 mg/mL | Generic | $11.39 per mL | n/a | -5% |
| Depo-testosterone 1,000 mg/10 mL | Brand | $6.92 per mL | n/a | +10% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has testosterone been recalled?
The FDA's Enforcement Report lists 220 recalls naming testosterone since 2013: 1 Class I (the most serious), 206 Class II, 13 Class III; 36 still ongoing. 150 of them are by firms that FDA's NDC Directory does not list as a maker of testosterone and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 26, 2026 | Class II | F.H. INVESTMENTS, Inc. (dba Asteria Health) | Presence of Foreign substance - potential presence of metal particulate matter |
| November 7, 2025 | Class III | Teva Pharmaceuticals USA, Inc | Defective Container - A defect in the side-seal which allows leakage of product. |
| October 14, 2025 | Class II | FARMAKEIO OUTSOURCING LLC not a listed maker | CGMP Deviations: Potential presence of metal particulate matter |
| June 16, 2025 | Class III | Qualgen, LLC not a listed maker | Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label. |
| May 2, 2025 | Class II | Empower Clinic Services, LLC dba Empower Pharmacy not a listed maker | Lack of Assurance of Sterility |
| April 10, 2025 | Class II | Eugia US LLC | cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. |
| March 5, 2025 | Class II | Strides Pharma, Inc. | Presence of foreign substance: Presence of Benzene. |
| August 8, 2024 | Class II | Teva Pharmaceuticals USA, Inc | Superpotent Drug |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the testosterone label say about other medicines?
The testosterone label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 19 other medicines name testosterone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Methyltestosterone | warnings and precautions | Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). |
| Warfarin | drug interactions | More frequent monitoring of International Normalized Ratio (INR) and prothrombin time is recommended in patients taking warfarin ( 7.2 ). |
Other labels that name testosterone
Source: FDA drug label (AZMIRO), Azurity Pharmaceuticals, Inc., effective July 25, 2025 (SPL set 235b5625-570d-3fba-e063-6394a90aa2d1), via openFDA; the full label on DailyMed
What do FAERS reports show for testosterone?
The FDA Adverse Event Reporting System holds 34,691 reports that list testosterone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,532 are coded as a death and 8,785 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as testosterone?
1 other medicine is given the same way (intramuscular) and in the same FDA class as testosterone or labeled mainly for the same use (breast cancer), the same class first. Breast cancer lists all 44 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intramuscular) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Fulvestrant | Breast cancer | 18 labelers | n/a | A presentation being discontinued |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other androgens
- the pharmacologic class, with prices and generics
- Testosterone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other