Quick answers
- What is Testosterone undecanoate used for?
- The FDA-approved label (Aveed, Endo USA, Inc., July 15, 2025) says: “AVEED is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Testosterone undecanoate have a boxed warning?
- Yes. The FDA label for Aveed has a boxed warning (“WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Testosterone undecanoate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Testosterone undecanoate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Testosterone undecanoate?
- 4 companies list prescription products of Testosterone undecanoate in the FDA NDC Directory, including Marius Pharmaceuticals, TOLMAR Inc. and Endo USA, Inc..
What Testosterone undecanoate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
AVEED is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. …
— FDA label: Aveed, Endo USA, Inc., effective July 15, 2025. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS
. Read it on the full label →
1 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| testosterone undecanoate 112.5 mg capsule, liquid filled | Brand: Tlando | $7.18 per capsule |
| testosterone undecanoate 158 mg capsule, liquid filled | Brand: Jatenzo | $8.96 per capsule |
| testosterone undecanoate 198 mg capsule, liquid filled | Brand: Jatenzo | $8.96 per capsule |
| testosterone undecanoate 237 mg capsule, liquid filled | Brand: Jatenzo | $17.93 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Marius Pharmaceuticals3 products
- TOLMAR Inc.3 products
- Endo USA, Inc.1 product
- Verity Pharmaceuticals Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022219 AVEED | Endo Operations | March 5, 2014 | 15, latest July 11, 2025 2025: Labeling · 2024: REMS · 2022: REMS |
| NDA206089 JATENZO | Tolmar | March 27, 2019 | 2, latest September 12, 2025 2025: Labeling · 2025: Labeling |
| NDA208088 TLANDO | Verity | March 28, 2022 | 1, latest July 11, 2025 2025: Labeling |
| NDA213953 KYZATREX | Marius | July 27, 2022 | 1, latest July 11, 2025 2025: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1490661, 1490667, 2599054, 2599060 |
|---|---|
| SPL set ID of the quoted label | f80f025b-17d8-40af-8739-20ce07902045 |
| FDA labels (SPL) | 2 |
| FDA applications | NDA022219, NDA206089, NDA208088, NDA213953 |
| Active ingredients (FDA) | TESTOSTERONE UNDECANOATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Aveed, Endo USA, Inc., effective July 15, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →