Active ingredient
Aliskiren
6 finished FDA listings contain Aliskiren as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ALISKIREN HEMIFUMARATE
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 3
- Strengths listed
- 150 mg/1 · 300 mg/1
- Brand names in FDA listings
- Aliskiren, Tekturna
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 325646
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 021985 | LXO IRELAND | 2007-03-05 | 4 |
| ANDA 206665 | PH HEALTH | 2019-03-22 | 2 |
Official labeling on DailyMed
- ALISKIREN TABLET, FILM COATED [PAR HEALTH USA, LLC] · version 30 · 2026-06-15
- ALISKIREN (ALISKIREN HEMIFUMARATE) TABLET, FILM COATED [PRASCO LABORATORIES] · version 18 · 2024-07-17
- TEKTURNA (ALISKIREN HEMIFUMARATE) TABLET, FILM COATED [LXO US INC.] · version 16 · 2024-03-12
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.