Quick answers
- What is Methyltestosterone used for?
- The FDA-approved label (Methitest, Amneal Pharmaceuticals of New York LLC, May 31, 2025) says: “1. Males Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenita or acquired) — Testicular failure due to cryptohidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Methyltestosterone have a boxed warning?
- No. None of the 3 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Methyltestosterone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Methyltestosterone been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Methyltestosterone?
- 2 companies list prescription products of Methyltestosterone in the FDA NDC Directory, including Amneal Pharmaceuticals of New York LLC and ANI Pharmaceuticals, Inc..
What Methyltestosterone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
1. Males Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenita or acquired) — Testicular failure due to cryptohidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy. …
— FDA label: Methitest, Amneal Pharmaceuticals of New York LLC, effective May 31, 2025. Read the full label on DailyMed →
The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Methitest |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Amneal Pharmaceuticals of New York LLC2 products
- ANI Pharmaceuticals, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (3)
- ANDA080767Impax Labs · October 17, 1974
- ANDA204851Impax Labs Inc · September 21, 2015
- ANDA215270Novitium Pharma · February 18, 2022
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 197975, 197976, 541524 |
|---|---|
| SPL set ID of the quoted label | 77bb4ef4-c10e-4acc-8225-651d003f4561 |
| FDA labels (SPL) | 3 |
| FDA applications | 3 ANDA |
| Active ingredients (FDA) | METHYLTESTOSTERONE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Methitest, Amneal Pharmaceuticals of New York LLC, effective May 31, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →