Medicine
Testosterone enanthate 1000 mg/5 mL injection
Testosterone enanthate 1000 mg/5 mL injection is a generic prescription medicine for intramuscular use, made by 2 labelers, 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
Testosterone enanthate injection, USP is a clear, colorless to pale yellow…
Key facts
- Active ingredient (INN)
- Testosterone enanthate
- Brand
- Sold under the generic name
- Strength
- 1000 mg/5 mL
- Dosage form
- Injection
- Route
- Intramuscular
- Packs
- 1 vial of 5 mL, 5 mL
- Manufacturers
- EugiaIndiaHikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Testosterone enanthate injection, USP is a clear, colorless to pale yellow color oily solution and is supplied as follows: 1,000 mg per 5 mL (200 mg/mL) 5 mL multiple-dose vial NDC 55150-336-01 packaged individually STORAGE Testosterone enanthate injection, USP should be stored at 20º to 25ºC (68º to 77ºF).
- 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
- 18 September 2012
- Identifiers
- RxCUI 835809DailyMed set ID 82a98132-9d5f-40a5-8c4f-f52f2a5de60e, e89d6458-428c-4256-97a3-f1fa851293c1NDC 55150-336, 0143-9750Application ANDA212659, ANDA091120
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 55150-336-01 | EugiaIndia | 28 February 2024 |
| 5 mL in 1 vial, multi-dose | 0143-9750-01 | Hikma Pharmaceuticals | 18 September 2012 |
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 Testosterone enanthate 1000 mg/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.