Medicine
Xyosted 100 mg/0.5 mL injection
Xyosted 100 mg/0.5 mL injection is a prescription medicine containing Testosterone enanthate for subcutaneous use, marketed by Antares Pharma, 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 controlled room temperature, 20°C to 25°C (68°F - 77°F), excursions…
Key facts
- Active ingredient (INN)
- Testosterone enanthate
- Brand
- Xyosted
- Strength
- 100 mg/0.5 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 4 syringes of 0.5 mL, 1 syringe of 0.5 mL
- Marketing authorisation holder
- Antares Pharma
- Manufacturer
- Antares Pharma
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature, 20°C to 25°C (68°F - 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light (keep in carton until time of use).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIII
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 November 2018
- Identifiers
- RxCUI 2099681, 2099686, 2099689 +3DailyMed set ID 8a3d204c-be26-49e0-8599-0ac12a272e81NDC 54436-200Application NDA209863
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 |
|---|---|---|---|
| 4 syringe in 1 carton / .5 mL in 1 syringe | 54436-200-04 | Antares Pharma | 15 November 2018 |
| 1 syringe in 1 carton / .5 mL in 1 syringe | 54436-200-05 | Antares Pharma | 8 January 2024 |
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 24 December 1953 | 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 enanthate
Clinical summary
Testosterone enanthate 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 injection for subcutaneous and intramuscular use. MedsAcross supplies Testosterone enanthate 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 enanthateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- XYOSTED prescribing information (Antares Pharma) · U.S. National Library of Medicine, DailyMed
Need Xyosted 100 mg/0.5 mL injection 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.