Active ingredient
Ketoprofen
7 finished FDA listings contain Ketoprofen as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- KETOPROFEN
- Dosage forms
- Capsule, Capsule, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 5
- Strengths listed
- 200 mg/1 · 25 mg/1 · 50 mg/1 · 75 mg/1
- Brand names in FDA listings
- Orudis
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 6142
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 |
|---|---|---|---|
| ANDA 074014 | MISEMER | 1993-01-29 | 6 |
| ANDA 075679 | MYLAN | 2002-02-20 | 1 |
Official labeling on DailyMed
- KETOPROFEN CAPSULE [MARNEL PHARMACEUTICALS, INC.] · version 1 · 2026-04-14
- KETOPROFEN CAPSULE [ONCORA PHARMA, LLC] · version 2 · 2026-03-10
- KETOPROFEN CAPSULE [MISEMER PHARMACEUTICALS, INC.] · version 11 · 2026-02-16
- ORUDIS (KETOPROFEN) CAPSULE [ALLEGIS PHARMACEUTICALS, INC.] · version 1 · 2026-01-12
- KETOPROFEN CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] · version 19 · 2024-11-11
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.