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Brand-name prescription medicine

Epclusa

Generic name: Velpatasvir and sofosbuvir

FDA application holder: Gilead Sciences Inc

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Epclusa?
Epclusa is a brand name of Velpatasvir and sofosbuvir, a prescription medicine. The FDA NDC Directory lists 4 Epclusa products in 4 strengths and forms.
Who makes Epclusa?
Gilead Sciences Inc holds the FDA application for Epclusa (NDA208341, approved June 28, 2016).
Is there a generic or store brand of Epclusa?
Yes. The FDA NDC Directory lists 1 other product with the same active ingredients, strength and form as a Epclusa product, 1 of them generic. Ask your pharmacist whether one is right for you.
What do pharmacies pay for Epclusa?
CMS lists a National Average Drug Acquisition Cost (NADAC) for 1 Epclusa strength and form (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
Has Epclusa been recalled?
No recall linked to Epclusa products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Epclusa is

Each Epclusa 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.

Velpatasvir and sofosbuvir · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
sofosbuvir 150 mg · velpatasvir 37.5 mg
pellet (oral)
Epclusa None listed DailyMed
sofosbuvir 200 mg · velpatasvir 50 mg
pellet (oral)
Epclusa None listed DailyMed
sofosbuvir 200 mg · velpatasvir 50 mg
tablet, film coated (oral)
Epclusa None listed DailyMed
sofosbuvir 400 mg · velpatasvir 100 mg
tablet, film coated (oral)
Epclusa 1 product, 1 company DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Velpatasvir and sofosbuvir →

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Epclusa products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA208341Gilead Sciences IncJune 28, 20162
NDA214187Gilead Sciences IncJune 10, 20212

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Epclusa, by strength and form
Strength and formGeneric or brandPharmacies pay
sofosbuvir 400 mg · velpatasvir 100 mg
tablet, film coated
Brand: Epclusa $864.99 per tablet
Generic of the same strength and form: $277.96 per tablet

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list Epclusa

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Epclusa products.

Recalls

No recall linked to Epclusa products (by their NDC code or label) appears in the FDA enforcement reports.

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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.

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