FDA label
What is Epclusa used for?
Epclusa contains velpatasvir and sofosbuvir. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “EPCLUSA is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection: without cirrhosis or with compensated cirrhosis; with decompensated cirrhosis for use in combination with ribavirin.”
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Epclusa, tablet, film coated
Indications and Usage, quoted from the label by Gilead Sciences, Inc. (NDA208341). Cross-references to other label sections are left out.
EPCLUSA is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection:
- without cirrhosis or with compensated cirrhosis
- with decompensated cirrhosis for use in combination with ribavirin.
Source: DailyMed label, set id 7f30631a-ee3b-4cfe-866b-964df3f0a44f, version 14, effective June 5, 2024. NDC 61958-2201, one of 2 listings for this product.
Questions
What is Epclusa used for?
The FDA label says: “EPCLUSA is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection: without cirrhosis or with compensated cirrhosis; with decompensated cirrhosis for use in combination with ribavirin.”
What drug class is Epclusa?
FDA lists velpatasvir and sofosbuvir in the Hepatitis C Virus NS5A Inhibitor and Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Epclusa
- Is Epclusa a controlled substance?Federal schedule
- Generic for EpclusaFDA Orange Book
- Is Velpatasvir and Sofosbuvir a controlled substance?Federal schedule
- Hepatitis C Virus NS5A Inhibitors listFDA drug class
- Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitors listFDA drug class
- Epclusa Medicare Part D coverageBy plan and state
- NDC 61958-2201Epclusa NDC record
- NDC 61958-2203Epclusa NDC record
- NDC 61958-2204Epclusa NDC record