Active ingredient
Iloperidone
18 finished FDA listings contain Iloperidone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ILOPERIDONE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 2
- Strengths listed
- 1 mg/1 · 10 mg/1 · 12 mg/1 · 2 mg/1 · 4 mg/1 · 6 mg/1 · 8 mg/1
- Brand names in FDA listings
- Fanapt
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 73178
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 022192 | VANDA PHARMS INC | 2009-05-06 | 11 |
| ANDA 207231 | ADAPTIS | 2016-11-28 | 7 |
Official labeling on DailyMed
- FANAPT (ILOPERIDONE) TABLET FANAPT (ILOPERIDONE) KIT [VANDA PHARMACEUTICALS INC.] · version 35 · 2026-05-13
- ILOPERIDONE TABLET [MYLAN PHARMACEUTICALS INC.] · version 10 · 2025-03-17
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.