Active ingredient
Sofosbuvir
4 finished FDA listings contain Sofosbuvir as their only active ingredient; 11 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- SOFOSBUVIR
- Dosage forms
- Pellet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 150 mg/1 · 200 mg/1 · 400 mg/1
- Brand names in FDA listings
- Sovaldi
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1484911
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 204671 | GILEAD SCIENCES INC | 2013-12-06 | 2 |
| NDA 212480 | GILEAD SCIENCES INC | 2019-08-28 | 2 |
Official labeling on DailyMed
- SOVALDI (SOFOSBUVIR) TABLET, FILM COATED SOVALDI (SOFOSBUVIR) PELLET [GILEAD SCIENCES, INC.] · version 16 · 2025-01-13
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.