Active ingredient
Metyrosine
4 finished FDA listings contain Metyrosine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- METYROSINE
- Dosage forms
- Capsule
- Routes
- Oral
- Manufacturers / labelers
- 4
- Strengths listed
- 250 mg/1
- Brand names in FDA listings
- Demser
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 266604
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 |
|---|---|---|---|
| NDA 017871 | BAUSCH | 1979-10-03 | 2 |
| ANDA 213734 | AMNEAL | 2020-07-24 | 1 |
| ANDA 218620 | DR REDDYS LABS SA | 2025-04-09 | 1 |
Official labeling on DailyMed
- METYROSINE CAPSULE [DR. REDDY'S LABORATORIES INC.] · version 1 · 2025-06-02
- DEMSER (METYROSINE) CAPSULE [BAUSCH HEALTH US, LLC] · version 10 · 2021-09-15
- METYROSINE CAPSULE [OCEANSIDE PHARMACEUTICALS] · version 4 · 2021-09-15
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.