Medicine
Methyltestosterone 10 mg capsule
Methyltestosterone 10 mg capsule is a generic prescription medicine for oral 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
Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Methyltestosterone
- Brand
- Sold under the generic name
- Strength
- 10 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 1000 capsules, 30 capsules and 1 more
- Manufacturers
- Amneal Pharmaceuticals of New YorkANI Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIII
- ATC code
- G03BA02 Methyltestosterone
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 21 September 2015
- Identifiers
- RxCUI 197975DailyMed set ID c09c4cde-9f6c-4c4f-9d96-18beb5377564, 9bed4886-fcd0-4056-be8d-5bb4d15081ceNDC 70954-255, 0115-1408Application ANDA215270, ANDA204851
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 |
|---|---|---|---|
| 100 capsule in 1 bottle | 0115-1408-01 | Amneal Pharmaceuticals of New York | 21 September 2015 |
| 1000 capsule in 1 bottle | 0115-1408-03 | Amneal Pharmaceuticals of New York | 21 September 2015 |
| 30 capsule in 1 bottle | 0115-1408-08 | Amneal Pharmaceuticals of New York | 21 September 2015 |
| 100 capsule in 1 bottle | 70954-255-10 | ANI Pharmaceuticals | 18 February 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 | Approved | 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 Methyltestosterone
Clinical summary
Methyltestosterone is an androgen indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. It is available as capsules and tablets for oral use. MedsAcross supplies Methyltestosterone 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 MethyltestosteroneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- METHITEST prescribing information (Amneal Pharmaceuticals of New York) · U.S. National Library of Medicine, DailyMed
Need Methyltestosterone 10 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.