Prescription medicine
Remdesivir Brand names: Veklury
Remdesivir (Veklury) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the remdesivir FDA label on DailyMed (effective July 29, 2026, Gilead Sciences, Inc.); the NDA 214787 record on Drugs@FDA; every remdesivir label on DailyMed.
Highlights of the record
FDA label of July 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVEKLURY is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg) who are [see Clinical Studies (14) ]: Hospitalized, or Not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.
Forms and strengths
- 100 mg
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- October 22, 2020 Veklury, Gilead Sciences Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- November 28, 2041 Veklury injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2021 2 Class I among all firms' recalls; latest September 19, 2024
- FAERS reports
- 13,249 through July 30, 2026
What is remdesivir used for?
From the label: indications and usageVEKLURY is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg) who are [see Clinical Studies (14) ]: Hospitalized, or Not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. […]
Conditions named in the indications of remdesivir's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor.
Source: FDA drug label (Veklury), Gilead Sciences, Inc., effective July 29, 2026 (SPL set c0978fa8-53ff-4ca2-82a7-567fd3e958ca), via openFDA; the full label on DailyMed
Is there a generic for remdesivir (Veklury)?
No generic remdesivir is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 16 patents for Veklury injection: the compound patent runs to October 29, 2035 (pediatric exclusivity to April 29, 2036), and the last listed entry to November 28, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2041 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has remdesivir been recalled?
The FDA's Enforcement Report lists 2 recalls naming remdesivir since 2021: 2 Class I (the most serious), 0 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 19, 2024 | Class I | Gilead Sciences, Inc. | Presence of Particulate Matter: Presence of glass particle. |
| December 3, 2021 | Class I | Gilead Sciences, Inc. | Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the remdesivir label say about other medicines?
The remdesivir label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Chloroquine | drug interactions | DRUG INTERACTIONS 7.1 Effects of Other Drugs on VEKLURY Due to potential antagonism based on data from cell culture experiments, concomitant use of VEKLURY with chloroquine phosphate or hydroxychloroquine sulfate is not recommended [see Warnings and Precautions (5.3) and Microbiology (12.4) ]. |
| Hydroxychloroquine | drug interactions | DRUG INTERACTIONS 7.1 Effects of Other Drugs on VEKLURY Due to potential antagonism based on data from cell culture experiments, concomitant use of VEKLURY with chloroquine phosphate or hydroxychloroquine sulfate is not recommended [see Warnings and Precautions (5.3) and Microbiology (12.4) ]. |
Source: FDA drug label (Veklury), Gilead Sciences, Inc., effective July 29, 2026 (SPL set c0978fa8-53ff-4ca2-82a7-567fd3e958ca), via openFDA; the full label on DailyMed
What do FAERS reports show for remdesivir?
The FDA Adverse Event Reporting System holds 13,249 reports that list remdesivir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,287 are coded as a death and 4,512 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2020 (4,479, against a median of 536 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Remdesivir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other