United States· US:80603-105_413922db-74d9-ab1f-e063-6394a90aba28
Kyzatrex
A medicinal product containing testosterone undecanoate, registered in United States by Marius Pharmaceuticals.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- TESTOSTERONE UNDECANOATE
- Manufacturer
- Marius Pharmaceuticals
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- August 30, 2026
Packs & prices · 6
- ndc11806031051190 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-105-11)
- ndc118060310522120 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-105-22)
- ndc11806031053360 CAPSULE, LIQUID FILLED in 1 BOTTLE (80603-105-33)
- ndc1180603-105-11
- ndc1180603-105-22
- ndc1180603-105-33
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Testosterone undecanoate in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwedenNebido 1000 mg/4 ml Injektionsvätska, lösningEbb Medical AB
- United KingdomNebido 1000mg/4ml solution for injection ampoulesBayer Plc
- GermanyNebidoGrünenthal Pharmaceuticals Gmbh & Co. Kg
- CzechiaNEBIDOBayer AG, Leverkusen
- FinlandNebidoGrünenthal Pharmaceuticals GmbH & Co. KG
- BelgiumNebido 1000 mg/4 mlPI Pharma
- IrelandNebido 1000 mg/4 ml, solution for injectionGrunenthal Pharma Limited.
- NorwayNebidoGrünenthal Pharmaceuticals GmbH & Co. KG
Authorised across Europe · EMA
The same active substance is authorised in 28 EEA countries. Names it is sold under:
- Austria · Nebido, Testomed
- Belgium · Nebido, Testosterone Besins
- Bulgaria · Небидо, Тестостерон Тева
- Cyprus · Nebido
- Czechia · Nebido, Testosteron Undekanoát Besins
- Germany · Nebido, Testogalen 3-Monats-Depot
- Denmark · Nebido, Testonur
- Spain · Reandron, Teneone
- Finland · Nebido, Testonur
- France · Nebido, Testosterone Besins
- United Kingdom (Northern Ireland) · Nebido, Ponsic
- Greece · Nebido
- Croatia · Nebido
- Hungary · Nebido, Testosterone Sun
- Ireland · Nebido, Testosterone Besins
- Iceland · Depotesto, Nebido
- Italy · Nebid, Testex
- Lithuania · Nebido, Testosterone Undecanoate Orifarm
- Luxembourg · Nebido, Testosterone Besins
- Malta · Nebido
- Netherlands · Nebido, Testosteron Teva
- Norway · Nebido, Testonur
- Poland · Nebido, Testosterone Undecanoate Besins
- Portugal · Nebido, Testosterona Besins
- Romania · Androject, Nebido
- Sweden · Nebido, Testonur
- Slovenia · Nebido
- Slovakia · Androject, Nebido
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/ecd4c3e3-3cb1-4115-9c8e-a6a8cab80b01 GET /v1/drugs/ecd4c3e3-3cb1-4115-9c8e-a6a8cab80b01?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "ORAL",
"source": "ndc",
"strength": "200",
"substance": "TESTOSTERONE UNDECANOATE",
"productndc": "80603-105",
"dosage_form": "CAPSULE, LIQUID FILLED",
"dea_schedule": "CIII",
"strength_unit": "mg/1",
"application_number": "NDA213953",
"marketing_category": "NDA"
}See everything about testosterone undecanoate.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.