Active ingredient
Orlistat
4 finished FDA listings contain Orlistat as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ORLISTAT
- Dosage forms
- Capsule
- Routes
- Oral
- Manufacturers / labelers
- 3
- Strengths listed
- 120 mg/1 · 60 mg/1
- Brand names in FDA listings
- Alli, Xenical
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 37925
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 020766 | CHEPLAPHARM | 1999-04-23 | 2 |
| NDA 021887 | HALEON US HOLDINGS | 2007-02-07 | 2 |
Official labeling on DailyMed
- ALLI (ORLISTAT) CAPSULE [HALEON US HOLDINGS LLC] · version 15 · 2026-03-20
- XENICAL (ORLISTAT) CAPSULE [H2-PHARMA LLC] · version 10 · 2026-01-12
- ORLISTAT CAPSULE [H2-PHARMA LLC] · version 7 · 2026-01-12
- ALLI (ORLISTAT) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ] · version 1 · 2024-04-01
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.