Active ingredient
Nepafenac
3 finished FDA listings contain Nepafenac as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- NEPAFENAC
- Dosage forms
- Suspension/ Drops
- Routes
- Ophthalmic
- Manufacturers / labelers
- 2
- Strengths listed
- 1 mg/ml · 3 mg/ml
- Brand names in FDA listings
- Ilevro, Nevanac
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 298665
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 021862 | HARROW EYE | 2005-08-19 | 1 |
| NDA 203491 | HARROW EYE | 2012-10-16 | 2 |
Official labeling on DailyMed
- ILEVRO (NEPAFENAC) SUSPENSION/ DROPS [HARROW EYE, LLC] · version 5 · 2026-04-03
- ILEVRO (NEPAFENAC) SUSPENSION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION] · version 5 · 2026-04-02
- NEVANAC (NEPAFENAC) SUSPENSION/ DROPS [HARROW EYE, LLC] · version 3 · 2025-11-17
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.