Active ingredient
Fenoprofen
11 finished FDA listings contain Fenoprofen as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- FENOPROFEN CALCIUM
- Dosage forms
- Capsule
- Routes
- Oral
- Manufacturers / labelers
- 6
- Strengths listed
- 200 mg/1 · 300 mg/1 · 400 mg/1
- Brand names in FDA listings
- Fenopron Tm
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 4331
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 214475 | RISING | 2022-07-18 | 7 |
| ANDA 215548 | MISEMER | 2023-05-16 | 4 |
Official labeling on DailyMed
- FENOPROFEN CALCIUM CAPSULE [MISEMER PHARMACEUTICALS, INC.] · version 8 · 2026-08-21
- FENOPROFEN CALCIUM CAPSULE [CORAL WAY PHARMA, LLC] · version 1 · 2026-08-03
- FENOPROFEN CALCIUM CAPSULE [ATLAND PHARMACEUTICALS, LLC] · version 1 · 2026-05-20
- FENOPRON TM (FENOPROFEN CALCIUM) CAPSULE [GALT PHARMACEUTICALS, LLC] · version 3 · 2026-02-27
- FENOPROFEN CALCIUM CAPSULE [RISING PHARMA HOLDINGS, INC.] · version 8 · 2025-12-09
- FENOPROFEN CALCIUM CAPSULE [ATLAND PHARMACEUTICALS, LLC] · version 1 · 2024-03-28
- FENOPROFEN CALCIUM CAPSULE [PROFICIENT RX LP] · version 1 · 2023-08-21
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.