Quick answers
- What is Harvoni?
- Harvoni is a brand name of Ledipasvir and sofosbuvir, a prescription medicine. The FDA NDC Directory lists 4 Harvoni products in 4 strengths and forms.
- Who makes Harvoni?
- Gilead Sciences Inc holds the FDA application for Harvoni (NDA205834, approved October 10, 2014).
- Is there a generic or store brand of Harvoni?
- Yes. The FDA NDC Directory lists 1 other product with the same active ingredients, strength and form as a Harvoni product, 1 of them generic. Ask your pharmacist whether one is right for you.
- Has Harvoni been recalled?
- No recall linked to Harvoni products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Harvoni is
Each Harvoni product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Ledipasvir and sofosbuvir · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| ledipasvir 33.75 mg · sofosbuvir 150 mg pellet (oral) | Harvoni | None listed | DailyMed |
| ledipasvir 45 mg · sofosbuvir 200 mg pellet (oral) | Harvoni | None listed | DailyMed |
| ledipasvir 45 mg · sofosbuvir 200 mg tablet, film coated (oral) | Harvoni | None listed | DailyMed |
| ledipasvir 90 mg · sofosbuvir 400 mg tablet, film coated (oral) | Harvoni | 1 product, 1 company | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Ledipasvir and sofosbuvir →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA205834 | Gilead Sciences Inc | October 10, 2014 | 2 |
| NDA212477 | Gilead Sciences Inc | August 28, 2019 | 2 |
Companies that list Harvoni
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Harvoni products.
- Gilead Sciences, Inc4 products
Recalls
No recall linked to Harvoni products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.