Active ingredient
Raltegravir
9 finished FDA listings contain Raltegravir as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- RALTEGRAVIR POTASSIUM
- Dosage forms
- Granule, For Suspension, Tablet, Chewable, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 5
- Strengths listed
- 100 mg/1 · 25 mg/1 · 400 mg/1 · 600 mg/1
- Brand names in FDA listings
- Isentress
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 719872
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 022145 | MSD SUB MERCK | 2007-10-12 | 5 |
| NDA 203045 | MSD SUB MERCK | 2011-12-21 | 2 |
| NDA 205786 | MSD SUB MERCK | 2013-12-20 | 1 |
| ANDA 203540 | HETERO LABS LTD III | 2024-12-19 | 1 |
Official labeling on DailyMed
- ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] · version 8 · 2026-07-15
- RALTEGRAVIR (RALTEGRAVIR) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] · version 1 · 2026-07-06
- ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME LLC] · version 70 · 2025-11-17
- ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED [PROFICIENT RX LP] · version 2 · 2024-10-10
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.