Active ingredient
Apremilast
3 finished FDA listings contain Apremilast as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- APREMILAST
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 20 mg/1 · 30 mg/1 · 75 mg/1
- Brand names in FDA listings
- Otezla
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1492727
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 205437 | AMGEN INC | 2014-03-21 | 2 |
| NDA 210745 | AMGEN INC | 2025-08-29 | 1 |
Official labeling on DailyMed
- OTEZLA (APREMILAST) TABLET, FILM COATED OTEZLA (APREMILAST) KIT [AMGEN, INC] · version 38 · 2026-09-11
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.