Active ingredient
Selexipag
27 finished FDA listings contain Selexipag as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- SELEXIPAG
- Dosage forms
- Injection, Powder, For Solution, Tablet, Coated, Tablet, Film Coated
- Routes
- Intravenous, Oral
- Manufacturers / labelers
- 3
- Strengths listed
- 100 ug/1 · 1000 ug/1 · 1200 ug/1 · 1400 ug/1 · 150 ug/1 · 1600 ug/1 · 1800 ug/10ml · 200 ug/1 · 400 ug/1 · 600 ug/1 · 800 ug/1
- Brand names in FDA listings
- Uptravi
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1729002
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 207947 | ACTELION | 2015-12-21 | 10 |
| NDA 214275 | ACTELION | 2021-07-29 | 1 |
| ANDA 214302 | ZYDUS LIFESCIENCES | 2022-12-21 | 16 |
Official labeling on DailyMed
- UPTRAVI (SELEXIPAG) TABLET, COATED UPTRAVI TITRATION PACK (SELEXIPAG) KIT UPTRAVI (SELEXIPAG) INJECTION, POWDER, FOR SOLUTION UPTRAVI (SELEXIPAG) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.] · version 26 · 2026-06-01
- SELEXIPAG TABLET, FILM COATED SELEXIPAG TITRATION PACK (SELEXIPAG) KIT [ZYDUS LIFESCIENCES LIMITED] · version 2 · 2025-12-09
- SELEXIPAG TABLET, FILM COATED SELEXIPAG TITRATION PACK (SELEXIPAG) KIT [ZYDUS PHARMACEUTICALS (USA) INC.] · version 3 · 2025-02-17
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.