Active ingredient
Riociguat
10 finished FDA listings contain Riociguat as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- RIOCIGUAT
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 2
- Strengths listed
- .5 mg/1 · 1 mg/1 · 1.5 mg/1 · 2 mg/1 · 2.5 mg/1
- Brand names in FDA listings
- Adempas
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1439816
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 204819 | BAYER HLTHCARE | 2013-10-08 | 5 |
| ANDA 211135 | MSN | 2022-09-01 | 5 |
Official labeling on DailyMed
- ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] · version 32 · 2026-08-19
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.