Active ingredient
Choline Fenofibrate
4 finished FDA listings contain Choline Fenofibrate as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CHOLINE FENOFIBRATE
- Dosage forms
- Capsule, Delayed Release
- Routes
- Oral
- Manufacturers / labelers
- 2
- Strengths listed
- 135 mg/1 · 45 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1433887
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 200750 | CHARTWELL RX | 2013-12-04 | 2 |
| ANDA 207796 | MACLEODS PHARMS | 2024-02-08 | 2 |
Official labeling on DailyMed
- FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [MACLEODS PHARMACEUTICALS LIMITED] · version 2 · 2025-07-11
- FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] · version 12 · 2023-12-18
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.