Medicine
Kyzatrex 150 mg capsule
Kyzatrex 150 mg capsule is a prescription medicine containing Testosterone undecanoate for oral use, marketed by Marius Pharmaceuticals, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C…
Key facts
- Active ingredient (INN)
- Testosterone undecanoate
- Brand
- Kyzatrex
- Strength
- 150 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 90 capsules, 120 capsules
- Marketing authorisation holder
- Marius Pharmaceuticals
- Manufacturer
- Marius Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). Store the capsules in a dry place avoiding exposure to excessive moisture and humid conditions.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIII
- ATC code
- G03BA03 Testosterone
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 July 2022
- Identifiers
- RxCUI 2609597, 2609603, 2609605 +5DailyMed set ID 7f7167a7-2a25-47e2-acf5-33f499fce971NDC 80603-103Application NDA213953
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 90 capsule, liquid filled in 1 bottle | 80603-103-11 | Marius Pharmaceuticals | 27 July 2022 |
| 120 capsule, liquid filled in 1 bottle | 80603-103-22 | Marius Pharmaceuticals | 27 July 2022 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 5 March 2014 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Testosterone undecanoate
Clinical summary
Testosterone undecanoate is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. It is available as capsules and injection for oral and intramuscular use. MedsAcross supplies Testosterone undecanoate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Testosterone undecanoateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Aveed prescribing information (Endo) · U.S. National Library of Medicine, DailyMed
Need Kyzatrex 150 mg capsule for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.