Active ingredient
Dolutegravir
5 finished FDA listings contain Dolutegravir as their only active ingredient; 3 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- DOLUTEGRAVIR SODIUM
- Dosage forms
- Tablet, Film Coated, Tablet, For Suspension
- Routes
- Oral
- Manufacturers / labelers
- 2
- Strengths listed
- 10 mg/1 · 25 mg/1 · 5 mg/1 · 50 mg/1
- Brand names in FDA listings
- Tivicay, Tivicay Pd
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1433868
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 204790 | VIIV HLTHCARE | 2013-08-12 | 4 |
| NDA 213983 | VIIV HLTHCARE | 2020-06-12 | 1 |
Official labeling on DailyMed
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.