Active substance
Testosterone undecanoate
- SFDA 2
- US FDA 5
- Health Canada 4
- US price lines 4
- NHS prices 1
- Safety 4
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| NEBIDO 1000 MG- 4 ML SOLUTION FOR INJ | 250 mg/ml | Solution · Intramuscular use | 1 Vial | SAR 322.05 | NCE · Prescription | BAYER PHARMA AG | Valid |
| ANDRIOL TESTOCAPS 40MG | 40 mg | Capsule · Oral use | 60 Tablet Container | SAR 90.10 | NCE · Prescription | ORGANON | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
HYPERPROLACTINEMIA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| AVEED | 750MG/3ML (250MG/ML) | injectable · intramuscular | ENDO OPERATIONS | Prescription | 5 Mar 2014 |
| JATENZO | 158MG; 198MG; 237MG | capsule · oral | TOLMAR | Prescription | 27 Mar 2019 |
| TLANDO | 112.5MG | capsule · oral | VERITY | Prescription | 28 Mar 2022 |
| KYZATREX | 150MG; 200MG; 50MG | capsule · oral | MARIUS | Prescription | 27 Jul 2022 |
| KYZATREX | 100MG | capsule · oral | MARIUS | Discontinued | 27 Jul 2022 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| JATENZO | 02563770 | 158 MG | CAPSULE · ORAL | TOLMAR INTERNATIONAL LTD. |
| JATENZO | 02563789 | 198 MG | CAPSULE · ORAL | TOLMAR INTERNATIONAL LTD. |
| JATENZO | 02563797 | 237 MG | CAPSULE · ORAL | TOLMAR INTERNATIONAL LTD. |
| TARO-TESTOSTERONE | 02421186 | 40 MG | CAPSULE · ORAL | TARO PHARMACEUTICALS INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | JATENZO 158 MG CAPSULE | $8.97187 | per EA | 23 Sep 2026 |
| US NADAC | JATENZO 198 MG CAPSULE | $8.9534 | per EA | 23 Sep 2026 |
| US NADAC | JATENZO 237 MG CAPSULE | $17.93094 | per EA | 23 Sep 2026 |
| US NADAC | TLANDO 112.5 MG CAPSULE | $7.16533 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Testosterone undecanoate 1g/4ml solution for injection vials | £120.72 | 1 vial | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 11 Jul 2025 AVEED — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 11 Jul 2025 JATENZO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 11 Jul 2025 KYZATREX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 11 Jul 2025 TLANDO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.