Active ingredient
Methyltestosterone
3 finished FDA listings contain Methyltestosterone as their only active ingredient; 25 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- METHYLTESTOSTERONE
- Dosage forms
- Capsule, Tablet
- Routes
- Oral
- Manufacturers / labelers
- 2
- Strengths listed
- 10 mg/1
- Brand names in FDA listings
- Methitest
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 6904
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 080767 | IMPAX LABS | 1974-10-17 | 1 |
| ANDA 204851 | IMPAX LABS INC | 2015-09-21 | 1 |
| ANDA 215270 | NOVITIUM PHARMA | 2022-02-18 | 1 |
Official labeling on DailyMed
- METHYLTESTOSTERONE CAPSULE [ANI PHARMACEUTICALS, INC.] · version 2 · 2025-07-21
- METHITEST (METHYLTESTOSTERONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] · version 17 · 2025-06-05
- METHYLTESTOSTERONE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] · version 21 · 2025-06-05
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.