Active ingredient
Methyldopa
4 finished FDA listings contain Methyldopa as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- METHYLDOPA
- Dosage forms
- Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 2
- Strengths listed
- 250 mg/1 · 500 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 6876
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 018934 | CHARTWELL RX | 1984-06-29 | 2 |
| ANDA 070076 | RISING | 1985-04-18 | 2 |
Official labeling on DailyMed
- METHYLDOPA TABLET [RISING PHARMA HOLDINGS, INC.] · version 3 · 2025-04-07
- METHYLDOPA TABLET, FILM COATED [CHARTWELL RX, LLC] · version 3 · 2025-03-28
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.