Quick answers
- What is Elbasvir and grazoprevir used for?
- The FDA-approved label (Zepatier, Merck Sharp & Dohme LLC, March 13, 2026) says: “ZEPATIER ® is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg. ZEPATIER is indicated for use with ribavirin in certain patient populations […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Elbasvir and grazoprevir have a boxed warning?
- Yes. The FDA label for Zepatier has a boxed warning (“WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Elbasvir and grazoprevir?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Elbasvir and grazoprevir been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Elbasvir and grazoprevir?
- 1 company lists prescription products of Elbasvir and grazoprevir in the FDA NDC Directory, including Merck Sharp & Dohme LLC.
What Elbasvir and grazoprevir is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ZEPATIER ® is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg. ZEPATIER is indicated for use with ribavirin in certain patient populations […]. …
— FDA label: Zepatier, Merck Sharp & Dohme LLC, effective March 13, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV
. Read it on the full label →
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Zepatier |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Merck Sharp & Dohme LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA208261 ZEPATIER | Msd Sub Merck | January 28, 2016 | 6, latest December 9, 2021 2021: Efficacy · 2019: Labeling · 2018: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1734636, 1734642 |
|---|---|
| SPL set ID of the quoted label | 164dc02a-9180-426a-b8b5-04ab39d2bbd4 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA208261 |
| Active ingredients (FDA) | ELBASVIR / GRAZOPREVIR |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zepatier, Merck Sharp & Dohme LLC, effective March 13, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →