Active ingredient
Rilpivirine
4 finished FDA listings contain Rilpivirine as their only active ingredient; 5 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- RILPIVIRINE, RILPIVIRINE HYDROCHLORIDE
- Dosage forms
- Tablet, Film Coated, Tablet, For Suspension
- Routes
- Oral
- Manufacturers / labelers
- 3
- Strengths listed
- 2.5 mg/1 · 25 mg/1
- Brand names in FDA listings
- Edurant, Edurant Ped
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1102270
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 202022 | JANSSEN PRODS | 2011-05-20 | 1 |
| NDA 219016 | JANSSEN PRODS | 2024-03-15 | 1 |
| ANDA 218798 | SOMERSET THERAPS LLC | 2026-01-29 | 1 |
| ANDA 219788 | LAURUS | 2026-07-10 | 1 |
Official labeling on DailyMed
- RILPIVIRINE TABLET, FILM COATED [LAURUS LABS LIMITED] · version 1 · 2026-07-16
- RILPIVIRINE TABLET, FILM COATED [SOMERSET THERAPEUTICS, LLC] · version 1 · 2026-02-09
- EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED EDURANT PED (RILPIVIRINE HYDROCHLORIDE) TABLET, FOR SUSPENSION [JANSSEN PRODUCTS, LP] · version 28 · 2025-09-01
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.