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Veklury remdesivir 100 mg Injection, Powder, Lyophilized, For Solution, 1 vial — NDC 61958-2901-01 package photo

Veklury remdesivir 100 mg Injection, Powder, Lyophilized, For Solution, 1 vial

by Gilead Sciences, Inc. · 1 VIAL, SINGLE-DOSE in 1 CARTON (61958-2901-1) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
NDC 61958-2901-01
🏷️ FDA NDC (as labeled) 61958-2901-1 billing pads the package segment with a zero
This package
Contains1 vial Pack sizes2 compare ↓
Also comes in: 1 vial 61958-2901-02
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Aug 20, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Past resolved recalls for this product (2)
Class I · Sep 19, 2024 · Terminated — Presence of Particulate Matter: Presence of glass particle. (Gilead Sciences, Inc.) · FDA recall D-0005-2025
Class I · Dec 3, 2021 · Terminated — Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates. (Gilead Sciences, Inc.) · FDA recall D-0299-2022
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Sep 2023. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 61958-2901-1
Product NDC 61958-2901
11-digit billing NDC 61958290101
NCPDP billing unit EA — each (per item)
RxCUI 2284960, 2367758, 2395502, 2395504
UNII 3QKI37EEHE
Application # NDA214787
SPL Set ID c0978fa8-53ff-4ca2-82a7-567fd3e958ca
Established class (EPC) SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Sep 2023)
Marketing start 2020-11-01
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance REMDESIVIR
GCN Seq No 080847
GCN 47828
HICL code 046410
Ingredient (HICL) Remdesivir
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W0
Therapeutic class — intermediate (HIC2) Antiviral Agents (Continued 1)
HIC3 code W0L
Therapeutic class — specific (HIC3) Antiviral - Rna Polymerase Inhibitor
AHFS code 08:18.32.00
AHFS class Nucleoside And Nucleotide Antivirals
FDB label name REMDESIVIR 100 MG VIAL (EUA)
FDB brand name Remdesivir (Eua)
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 61958-2901-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 61958-2901-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor class.

Pharmacologic class SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor
Drug family (ATC) Nucleosides and nucleotides excl. reverse transcriptase inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerGilead Sciences, Inc.
Application holderGILEAD SCIENCES INC
FDA applicationNDA214787 (NDA)
Labeler code61958
First marketedNov 2020
Product typeHuman Prescription Drug
Portfolio42 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name REMDESIVIR 100 MG VIAL (EUA) Ingredient Remdesivir
📖 What it is MedlinePlus · NLM

Remdesivir injection is used to treat coronavirus disease 2019 (COVID-19 infection) caused by the SARS-CoV-2 virus in hospitalized adults and children who weigh at least 3 pounds (1.5 kg). Remdesivir injection is also used to treat coronavirus disease 2019 (COVID-19 infection) caused by the SARS-CoV-2 virus in non-hospitalized adults and children 28 days and older who weigh at least 6.6 pounds (3 kg) who are at high risk of progression to severe COVID-19, including hospitalization and death. Remdesivir is in a class of medications called antivirals. It works by stopping the virus from spreadin...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Veklury is the brand name for remdesivir, an antiviral medication that fights the SARS-CoV-2 virus — the one that causes COVID-19. Your doctor prescribed it either because you're h...
  • What exactly is Veklury and why has my doctor prescribed it?
  • No, Veklury isn't a pill. It's given as an IV infusion — a slow drip directly into a vein — by a nurse or other healthcare provider. Each infusion takes anywhere from 30 minutes to...
  • How will I receive this medication — do I take a pill?
📖 Read our full Remdesivir Injection guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2PP9364507
    A modified form of beta-cyclodextrin, a natural sugar-like molecule. It helps dissolve and stabilize drugs in liquid medicines and improves how well the body absorbs certain medications.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 1 vial
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Veklury 100 mgthis 61958-2901-01 Gilead 1 vial — — Discontinued —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2020
First FDA approval
Oct 2020
📍
2026
Currently FDA-listed
6 years listed
🛡️
2041
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Nov 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 22, 2020 RLD RS ⏳ ~15.2 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11975012 — method of use (U-3835)
US 11975012 — method of use (U-3836)
US 11975012 — method of use (U-3833)
US 11975012 — method of use (U-3834)
US 11007208 — method of use (U-3829)
US 11007208 — method of use (U-3830)
US 11266681 — method of use (U-3832)
US 11266681 — method of use (U-3831)
US 11382926 — method of use (U-3831)
US 11382926 — method of use (U-3832)
US 11382926 — method of use (U-3830)
US 11382926 — method of use (U-3829)
US 10695361 — method of use (U-3831)
US 10695361 — method of use (U-3832)
US 10695361 — method of use (U-3829)
US 10695361 — method of use (U-3830)
US 11903953 — method of use (U-3833)
US 11903953 — method of use (U-3834)
US 11491169 — method of use (U-3834)
US 11491169 — method of use (U-3833)
US 11491169 — method of use (U-3836)
US 11491169 — method of use (U-3835)
US 11007208 — method of use (U-3831)
US 11007208 — method of use (U-3832)
US 11903953 — method of use (U-3835)
US 11903953 — method of use (U-3836)
US 9949994 — drug substance
US 11492353 — drug substance
US 8318682 — drug substance
US 8318682 — drug substance
US 8008264 — drug substance
US RE46762 — drug substance
US 9724360 — drug substance
US 10065958 — drug substance
US RE46762 — drug substance
US 10065958 — drug substance
US 11975017 — drug product
US 11492353 — drug substance
US 8008264 — drug substance
US 9724360 — drug substance
US 10675296 — drug product
US 9949994 — drug substance
US 11492353*PED — drug product
US 11492353*PED — drug product
US 11491169*PED — drug product
US 11491169*PED — drug product
US 11903953*PED — drug product
US 11903953*PED — drug product
US 11007208*PED — drug product
US 11007208*PED — drug product
US 11382926*PED — drug product
US 11382926*PED — drug product
US 9949994*PED — drug product
US 10675296*PED — drug product
US 8008264*PED — drug product
US 8318682*PED — drug product
US 10065958*PED — drug product
US 10695361*PED — drug product
US RE46762*PED — drug product
US 9724360*PED — drug product
US 8008264*PED — drug product
US 10065958*PED — drug product
US 9949994*PED — drug product
US 8318682*PED — drug product
US RE46762*PED — drug product
US 10695361*PED — drug product
US 9724360*PED — drug product
US 11266681*PED — drug product
US 11975017*PED — drug product
US 11975012*PED — drug product
US 11975012*PED — drug product
Exclusivity M-301
Exclusivity NCE
Exclusivity M-301
Exclusivity NCE
Exclusivity PED
Exclusivity PED
Exclusivity PED
Exclusivity PED
2020 2022 2024 2026 2028 2030 2032 2034 2036 2038 2040 2042
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (71)
PatentTypeUse codeExpires
US 11975012 ↗ Method of use U-3835 May 28, 2041
US 11975012 ↗ Method of use U-3836 May 28, 2041
US 11975012 ↗ Method of use U-3833 May 28, 2041
US 11975012 ↗ Method of use U-3834 May 28, 2041
US 11007208 ↗ Method of use U-3829 Sep 16, 2036
US 11007208 ↗ Method of use U-3830 Sep 16, 2036
US 11266681 ↗ Method of use U-3832 Jul 10, 2038
US 11266681 ↗ Method of use U-3831 Jul 10, 2038
US 11382926 ↗ Method of use U-3831 Sep 16, 2036
US 11382926 ↗ Method of use U-3832 Sep 16, 2036
US 11382926 ↗ Method of use U-3830 Sep 16, 2036
US 11382926 ↗ Method of use U-3829 Sep 16, 2036
US 10695361 ↗ Method of use U-3831 Sep 16, 2036
US 10695361 ↗ Method of use U-3832 Sep 16, 2036
US 10695361 ↗ Method of use U-3829 Sep 16, 2036
US 10695361 ↗ Method of use U-3830 Sep 16, 2036
US 11903953 ↗ Method of use U-3833 May 28, 2041
US 11903953 ↗ Method of use U-3834 May 28, 2041
US 11491169 ↗ Method of use U-3834 May 28, 2041
US 11491169 ↗ Method of use U-3833 May 28, 2041
US 11491169 ↗ Method of use U-3836 May 28, 2041
US 11491169 ↗ Method of use U-3835 May 28, 2041
US 11007208 ↗ Method of use U-3831 Sep 16, 2036
US 11007208 ↗ Method of use U-3832 Sep 16, 2036
US 11903953 ↗ Method of use U-3835 May 28, 2041
US 11903953 ↗ Method of use U-3836 May 28, 2041
US 9949994 ↗ Drug substance — Oct 29, 2035
US 11492353 ↗ Drug substance — Dec 8, 2031
US 8318682 ↗ Drug substance — Apr 22, 2029
US 8318682 ↗ Drug substance — Apr 22, 2029
US 8008264 ↗ Drug substance — Sep 6, 2029
US RE46762 ↗ Drug substance — Apr 22, 2029
US 9724360 ↗ Drug substance — Oct 29, 2035
US 10065958 ↗ Drug substance — Nov 18, 2032
US RE46762 ↗ Drug substance — Apr 22, 2029
US 10065958 ↗ Drug substance — Nov 18, 2032
US 11975017 ↗ Drug product — Jul 10, 2038
US 11492353 ↗ Drug substance — Dec 8, 2031
US 8008264 ↗ Drug substance — Sep 6, 2029
US 9724360 ↗ Drug substance — Oct 29, 2035
US 10675296 ↗ Drug product — Jul 10, 2038
US 9949994 ↗ Drug substance — Oct 29, 2035
US 11492353*PED ↗ Drug product — Jun 8, 2032
US 11492353*PED ↗ Drug product — Jun 8, 2032
US 11491169*PED ↗ Drug product — Nov 28, 2041
US 11491169*PED ↗ Drug product — Nov 28, 2041
US 11903953*PED ↗ Drug product — Nov 28, 2041
US 11903953*PED ↗ Drug product — Nov 28, 2041
US 11007208*PED ↗ Drug product — Mar 16, 2037
US 11007208*PED ↗ Drug product — Mar 16, 2037
US 11382926*PED ↗ Drug product — Mar 16, 2037
US 11382926*PED ↗ Drug product — Mar 16, 2037
US 9949994*PED ↗ Drug product — Apr 29, 2036
US 10675296*PED ↗ Drug product — Jan 10, 2039
US 8008264*PED ↗ Drug product — Mar 6, 2030
US 8318682*PED ↗ Drug product — Oct 22, 2029
US 10065958*PED ↗ Drug product — May 18, 2033
US 10695361*PED ↗ Drug product — Mar 16, 2037
US RE46762*PED ↗ Drug product — Oct 22, 2029
US 9724360*PED ↗ Drug product — Apr 29, 2036
US 8008264*PED ↗ Drug product — Mar 6, 2030
US 10065958*PED ↗ Drug product — May 18, 2033
US 9949994*PED ↗ Drug product — Apr 29, 2036
US 8318682*PED ↗ Drug product — Oct 22, 2029
US RE46762*PED ↗ Drug product — Oct 22, 2029
US 10695361*PED ↗ Drug product — Mar 16, 2037
US 9724360*PED ↗ Drug product — Apr 29, 2036
US 11266681*PED ↗ Drug product — Jan 10, 2039
US 11975017*PED ↗ Drug product — Jan 10, 2039
US 11975012*PED ↗ Drug product — Nov 28, 2041
US 11975012*PED ↗ Drug product — Nov 28, 2041
FDA exclusivity
CodeWhat it grantsExpires
M-301New indication / labeling change (3-year)Jul 13, 2026
NCENew Chemical Entity (5-year)Oct 22, 2025
M-301New indication / labeling change (3-year)Jul 13, 2026
NCENew Chemical Entity (5-year)Oct 22, 2025
PEDPediatric Exclusivity (+6 months)Apr 22, 2026
PEDPediatric Exclusivity (+6 months)Apr 22, 2026
PEDPediatric Exclusivity (+6 months)Jan 13, 2027
PEDPediatric Exclusivity (+6 months)Jan 13, 2027
Common questions
Is there a generic version of REMDESIVIR 100 MG VIAL (EUA)?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for REMDESIVIR 100 MG VIAL (EUA). Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Nov 2041 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 vial61958-2901-02 1,078 Rx · $858,427
1 vial this page61958-2901-01 No Medicaid data
Drug total (last 4 qtrs): 1,078 Rx · 3,162 units · $858,427 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Veklury — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Veklury. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$45.7K
Claims incl. refills
31
Beneficiaries
16
Spend / beneficiary
$2,854.20
Spend / claim
$1,473.14
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Remdesivir — the ingredient across all brands.

Top reported reactions

Alanine Aminotransferase Increased935
Covid-19914
Death759
Bradycardia652
Aspartate Aminotransferase Increased629
Acute Kidney Injury626
Respiratory Failure536

Age at onset

Neonate96
Infant31
Child60
Adolescent51
Adult2,050
Elderly2,406

Reporter sex

13,249 reports
Male · 60%
Female · 40%
Unknown · 0%

Serious outcomes

Hospitalization4,512
Death3,287
Life-threatening1,445
Disabling156
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,479 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
61958-2901-01 You're viewing this 1 VIAL, SINGLE-DOSE in 1 CARTON (61958-2901-1) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2020-05-01 Discontinued by firm
61958-2901-02 1 VIAL, SINGLE-DOSE in 1 CARTON (61958-2901-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2020-11-01 Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 61958-2901-01?
NDC 61958-2901-01 contains 1 vial — 1 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose.
What is the difference between NDC 61958-2901-01 and NDC 61958-2901-02?
Both are Veklury remdesivir 100 mg Injection, Powder, Lyophilized, For Solution — the drug itself is identical. NDC 61958-2901-01 is the 1 vial package, while NDC 61958-2901-02 is the 1 vial package.
What NDC number is used to bill for this package of Veklury remdesivir 100 mg Injection, Powder, Lyophilized, For Solution?
Bill NDC 61958-2901-01 — the 11-digit billing format is 61958290101. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
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Inactive ingredients (structured) ✓ Available
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Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 61958-2901-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 61958-2901-01, written without dashes as 61958290101. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 61958-2901-01, the first segment (61958) is the labeler code FDA assigned to Gilead Sciences, Inc.; the middle segment (2901) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 vial (61958-2901-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Gilead Sciences, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 132 words ▾

1 INDICATIONS AND USAGE VEKLURY 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. VEKLURY is a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleotide analog RNA polymerase inhibitor 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: 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.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Testing: In all patients, before starting VEKLURY and during treatment as clinically appropriate, perform hepatic laboratory testing. Assess prothrombin time before starting VEKLURY and monitor as clinically appropriate. ( 2.2 ) Recommended dosage: Adults and pediatric patients weighing at least 40 kg: a single loading dose of VEKLURY 200 mg on Day 1 followed by once-daily maintenance doses of VEKLURY 100 mg from Day 2 via intravenous infusion.

( 2.3 ) Pediatric patients (birth to less than 18 years of age) weighing 1.5 kg to less than 40 kg: Recommended dosage is based on weight. Refer to Table 1 of the full prescribing information for specific dosing guidelines based on body weight. ( 2.3 ) Hospitalized patients: The treatment course of VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19 has been made.

( 2.3 ) For hospitalized patients requiring invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days. ( 2.3 ) For hospitalized patients not requiring invasive mechanical ventilation and/or ECMO, the recommended treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days.

( 2.3 ) Non-hospitalized patients: The treatment course of VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19 has been made and within 7 days of symptom onset. ( 2.3 ) For non-hospitalized patients diagnosed with mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death, the recommended total treatment duration is 3 days ( 2.3 ). Renal impairment: No dosage adjustment of VEKLURY is recommended in patients with any degree of renal impairment, including those on dialysis.

( 2.4 ) Administer VEKLURY via intravenous (IV) infusion over 30 to 120 minutes. ( 2.5 ) Dose preparation and administration: Refer to the full prescribing information for further details. ( 2.5 ) Storage of prepared dosages: VEKLURY contains no preservative.

( 2.6 )

2.1Dosage and Administration Overview VEKLURY may only be administered in settings in which healthcare providers have immediate access to medications to treat a severe infusion or hypersensitivity reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary [see Dosage and Administration (2.5) , Warnings and Precautions (5.1) ] . Administer VEKLURY for the treatment of COVID-19 in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg) by intravenous infusion only.

Do not administer by any other route. VEKLURY for injection must be reconstituted with Sterile Water for Injection prior to diluting with 0.9% sodium chloride injection.

2.2Testing Before Starting and During Treatment with VEKLURY Perform hepatic laboratory testing in all patients before starting VEKLURY and while receiving VEKLURY as clinically appropriate [see Warnings and Precautions (5.2) and Use in Specific Populations (8.7) ]. Determine prothrombin time in all patients before starting VEKLURY and monitor while receiving VEKLURY as clinically appropriate [see Adverse Reactions (6.1) ].

2.3Recommended Dosage in Adults and Pediatric Patients (Birth to Less than 18 Years of Age Weighing at Least 1.5 kg) The recommended dosage for adults and pediatric patients weighing at least 40 kg is a single loading dose of VEKLURY 200 mg on Day 1 via intravenous infusion followed by once-daily maintenance doses of VEKLURY 100 mg from Day 2 via intravenous infusion. The recommended dosage for pediatric patients weighing 1.5 kg to less than 40 kg is presented in Table 1. Table 1 Recommended Dosage in Pediatric Patients Including Term Gestational age greater than 37 weeks.

Neonates and Infants Weighing 1.5 kg to Less than 40 kg Pediatric Patient Population Loading Dose Via Intr…

💊 Dosage Forms and Strengths 44 words ▾

3 DOSAGE FORMS AND STRENGTHS VEKLURY for injection, 100 mg, available as a sterile, preservative-free white to off-white to yellow lyophilized powder in single-dose vial for reconstitution. For injection: 100 mg of remdesivir as a lyophilized powder, in a single-dose vial. ( 3 )

⛔ Contraindications 53 words ▾

4 CONTRAINDICATIONS VEKLURY is contraindicated in patients with a history of clinically significant hypersensitivity reactions to VEKLURY or any components of the product [see Warnings and Precautions (5.1) ]. VEKLURY is contraindicated in patients with a history of clinically significant hypersensitivity reactions to VEKLURY or any components of the product. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity including infusion-related and anaphylactic reactions: Hypersensitivity reactions have been observed during and following administration of VEKLURY. Slower infusion rates, with a maximum infusion time of up to 120 minutes, can be considered to potentially prevent signs and symptoms of hypersensitivity. Monitor patients during infusion and observe patients for at least one hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate.

If signs and symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue administration of VEKLURY and initiate appropriate treatment. ( 5.1 ) Increased risk of transaminase elevations: Transaminase elevations have been observed in healthy volunteers and have also been reported in patients with COVID-19 who received VEKLURY. Perform hepatic laboratory testing in all patients before starting VEKLURY and while receiving VEKLURY as clinically appropriate.

Consider discontinuing VEKLURY if ALT levels increase to greater than 10 times the upper limit of normal. Discontinue VEKLURY if ALT elevation is accompanied by signs or symptoms of liver inflammation. ( 5.2 ) Risk of reduced antiviral activity when coadministered with chloroquine phosphate or hydroxychloroquine sulfate: Coadministration of VEKLURY and chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on data from cell culture experiments demonstrating a potential antagonistic effect of chloroquine on the intracellular metabolic activation and antiviral activity of VEKLURY.

( 5.3 )

5.1Hypersensitivity Including Infusion-related and Anaphylactic Reactions Hypersensitivity reactions, including infusion-related and anaphylactic reactions, have been observed during and following administration of VEKLURY; most occurred within one hour. Signs and symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates, with a maximum infusion time of up to 120 minutes, can be considered to potentially prevent these signs and symptoms.

Monitor patients during infusion and observe patients for at least one hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate. If signs and symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue administration of VEKLURY and initiate appropriate treatment. The use of VEKLURY is contraindicated in patients with known hypersensitivity to VEKLURY or any components of the product [see Contraindications (4) ] .

5.2Increased Risk of Transaminase Elevations Transaminase elevations have been observed in healthy volunteers who received 200 mg of VEKLURY followed by 100 mg doses for up to 10 days; the transaminase elevations were mild (Grade 1) to moderate (Grade 2) in severity and resolved upon discontinuation of VEKLURY. Transaminase elevations have also been reported in patients with COVID-19 who received VEKLURY [see Adverse Reactions (6.1) ] . Because transaminase elevations have been reported as a clinical feature of COVID-19, and the incidence was similar in patients receiving placebo versus VEKLURY in clinical trials of VEKLURY, discerning the contribution of VEKLURY to transaminase elevations in patients with COVID-19 can be challenging.

Perform hepatic laboratory testing in all patients before starting VEKLURY and while receiving VEKLURY as clinically appropriate [see Dosage and Administration (2.1) and Use in Specific Populations (8.7) ] . Consider discontinuing VEKLURY if ALT levels increase to greater than 10 times the upper limit of normal. Discontinue VEKLURY if ALT elevation is accompanied by signs or symptoms of liver inflammation.

5.3Risk of Reduced Antiviral Activity When Coadministered with Chloroquine Phosphate or Hydroxychloroquine Sulfate Coadministration of VEKLURY and chl…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: Hypersensitivity Including Infusion-related and Anaphylactic Reactions [see Warnings and Precautions (5.1) ] Increased Risk of Transaminase Elevations [see Warnings and Precautions (5.2) ] The most common adverse reactions (incidence greater than or equal to 5%, all grades) observed with treatment with VEKLURY are nausea, ALT increased, and AST increased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials in Adult Subjects The safety of VEKLURY is based on data from four Phase 3 studies in 1,476 hospitalized adult subjects with COVID-19, one Phase 3 study in 279 non-hospitalized adult and pediatric subjects (12 years of age and older weighing at least 40 kg) with mild-to-moderate COVID-19, four Phase 1 studies in 131 healthy adults, and from patients with COVID-19 who received VEKLURY under the Emergency Use Authorization or in a compassionate use program.

Clinical Trials Experience in Adults with COVID-19 NIAID ACTT-1 was a randomized, double-blind, placebo-controlled clinical trial in hospitalized subjects with mild, moderate, and severe COVID-19 treated with VEKLURY (n=532) or placebo (n=516) for up to 10 days. Subjects treated with VEKLURY received 200 mg on Day 1 and 100 mg once daily on subsequent days [see Clinical Studies (14.1) ] . The collection of adverse event data in this trial was limited to severe (Grade 3) or potentially life-threatening (Grade 4) adverse events, serious adverse events, adverse events leading to study drug discontinuation, and moderate (Grade 2) severity or higher hypersensitivity reactions.

Rates of adverse reactions (≥ Grade 3), serious adverse reactions, and adverse reactions leading to treatment discontinuation are presented in Table 4. Table 4 Summary of Adverse Reaction Rates in Hospitalized Subjects with Mild, Moderate, or Severe COVID-19 in NIAID ACTT-1 Types of Adverse Reactions VEKLURY N=532 n (%) Placebo N=516 n (%) Adverse reactions, Grades ≥3 41 (8%) 46 (9%) Serious adverse reactions 2 (0.4%) Seizure (n=1), infusion-related reaction (n=1). 3 (0.6%) Adverse reactions leading to treatment discontinuation 11 (2%) Seizure (n=1), infusion-related reaction (n=1), transaminases increased (n=3), ALT increased and AST increased (n=1), GFR decreased (n=2), acute kidney injury (n=3).

15 (3%) Study GS-US-540-5773 was a randomized, open-label clinical trial in hospitalized subjects with severe COVID-19 treated with VEKLURY 200 mg on Day 1 and 100 mg once daily for 5 (n=200) or 10 days (n=197). Adverse reactions were reported in 33 (17%) subjects in the 5-day group and 40 (20%) subjects in the 10-day group [see Clinical Studies (14.2) ] . The most common adverse reactions occurring in at least 5% of subjects in either the VEKLURY 5-day or 10-day group, respectively, were nausea (5% vs 3%), AST increased (3% vs 6%), and ALT increased (2% vs 7%).

Rates of any adverse reactions, serious adverse reactions, and adverse reactions leading to treatment discontinuation are presented in Table 5. Table 5 Summary of Adverse Reaction Rates in Hospitalized Subjects with Severe COVID-19 in Study 5773 Types of Adverse Reactions VEKLURY 5 Days N=200 n (%) VEKLURY 10 Days N=197 n (%) Any adverse reaction, all Grades 33 (17%) 40 (20%) Serious adverse reactions 3 (2%) Transaminases increased (n=5), hepatic enzyme increased (n=1), hypertransaminasaemia (n=1). 4 (2%) Adverse reactions leading to treatment discontinuation 5 (3%) Transaminases increased (n=4), hepatic enzyme increased (n=2), LFT increased (n=2), hypertrans…

🔄 Drug Interactions 114 words ▾

7 DRUG INTERACTIONS

7.1Effects 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) ]. Based on drug interaction studies conducted with VEKLURY, no clinically significant drug interactions are expected with inducers of cytochrome P450 (CYP) 3A4 or inhibitors of Organic Anion Transporting Polypeptides (OATP) 1B1/1B3 and, P-glycoprotein (P-gp) [see Clinical Pharmacology (12.3) ].

7.2Effects of VEKLURY on Other Drugs Based on drug interaction studies conducted with VEKLURY, it is a weak inhibitor of CYP3A and does not inhibit OATP1B1/1B3 [see Clinical Pharmacology (12.3) ].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data from a clinical trial (IMPAACT 2032), published reports, the COVID-PR pregnancy exposure registry, and compassionate use of remdesivir in pregnant individuals have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes following exposure in the second and third trimester. However, there are insufficient pregnancy data available to evaluate the risk of remdesivir exposure during the first trimester. A study evaluating the pharmacokinetics of remdesivir during pregnancy demonstrated no clinically relevant differences between pregnant and non-pregnant individuals.

No dose adjustments are recommended in patients who receive VEKLURY during pregnancy (see Data ) and [see Clinical Pharmacology (12.3) ] . In nonclinical reproductive toxicity studies, remdesivir demonstrated no adverse effect on embryo-fetal development when administered to pregnant animals at systemic exposures (AUC) of the predominant circulating metabolite of remdesivir (GS-441524) that were 4 times (rats and rabbits) the exposure in humans at the recommended human dose (RHD) (see Data ). There are maternal and fetal risks associated with untreated COVID-19 in pregnancy (see Clinical Considerations ).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations Disease-associated maternal and/or embryo-fetal risk COVID-19 in pregnancy is associated with adverse maternal and fetal outcomes, including preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease, and fetal death. Data Human Data A non-randomized, open-label clinical study (IMPAACT 2032) evaluated pharmacokinetics and safety of up to 10 days of treatment with VEKLURY in 25 hospitalized pregnant and 28 hospitalized non-pregnant individuals of childbearing potential.

Subjects received VEKLURY 200 mg once daily for 1 day followed by VEKLURY 100 mg once daily on subsequent days via intravenous infusion. Subjects were enrolled prior to their fourth VEKLURY infusion. Assessments occurred at the following intervals: Screening; Pre-infusion (defined as 48 hours prior to start of first infusion); each infusion day; 48 hours after the last infusion; 7 days after the last infusion; 4 weeks after the last infusion.

Assessments also occurred 24 hours post-delivery in subjects who delivered. Treatment with VEKLURY was stopped in subjects who were discharged from the hospital prior to the completion of 10 days of treatment. Of the 25 pregnant subjects, median age was 33 years (Q1, Q3: 27 years, 37 years); 40% were White, 24% were Black, and 48% were Hispanic or Latino.

A total of 9 subjects (36%) were on high-flow oxygen; 12 subjects (48%) were on low-flow oxygen; and 1 subject (4%) was on room air, at baseline. Three subjects (12%) did not have data available on baseline oxygen status. The overall median (Q1, Q3) duration of symptoms prior to hospitalization was 7 (6, 9) days.

The overall median (Q1, Q3) duration of symptoms prior to first dose of VEKLURY was 8 (6, 9) days. Of the 25 pregnant subjects, median gestational age was 28 weeks at baseline (range 22 to 33 weeks) and about half of subjects were in each of the second and third trimester of pregnancy. No clinically relevant differences in the pharmacokinetics of remdesivir or its metabolites (GS-704277 and GS-441524) were observed between pregnant (n=21) and non-pregnant (n=22) individuals [see Clinical Pharmacology (12.3) ] .

No difference in pharmacokinetics of remdesivir or its metabolites is expected between the first and second/third trimesters. The adverse reacti…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Available data from a clinical trial (IMPAACT 2032), published reports, the COVID-PR pregnancy exposure registry, and compassionate use of remdesivir in pregnant individuals have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes following exposure in the second and third trimester. However, there are insufficient pregnancy data available to evaluate the risk of remdesivir exposure during the first trimester. A study evaluating the pharmacokinetics of remdesivir during pregnancy demonstrated no clinically relevant differences between pregnant and non-pregnant individuals.

No dose adjustments are recommended in patients who receive VEKLURY during pregnancy (see Data ) and [see Clinical Pharmacology (12.3) ] . In nonclinical reproductive toxicity studies, remdesivir demonstrated no adverse effect on embryo-fetal development when administered to pregnant animals at systemic exposures (AUC) of the predominant circulating metabolite of remdesivir (GS-441524) that were 4 times (rats and rabbits) the exposure in humans at the recommended human dose (RHD) (see Data ). There are maternal and fetal risks associated with untreated COVID-19 in pregnancy (see Clinical Considerations ).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations Disease-associated maternal and/or embryo-fetal risk COVID-19 in pregnancy is associated with adverse maternal and fetal outcomes, including preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease, and fetal death. Data Human Data A non-randomized, open-label clinical study (IMPAACT 2032) evaluated pharmacokinetics and safety of up to 10 days of treatment with VEKLURY in 25 hospitalized pregnant and 28 hospitalized non-pregnant individuals of childbearing potential.

Subjects received VEKLURY 200 mg once daily for 1 day followed by VEKLURY 100 mg once daily on subsequent days via intravenous infusion. Subjects were enrolled prior to their fourth VEKLURY infusion. Assessments occurred at the following intervals: Screening; Pre-infusion (defined as 48 hours prior to start of first infusion); each infusion day; 48 hours after the last infusion; 7 days after the last infusion; 4 weeks after the last infusion.

Assessments also occurred 24 hours post-delivery in subjects who delivered. Treatment with VEKLURY was stopped in subjects who were discharged from the hospital prior to the completion of 10 days of treatment. Of the 25 pregnant subjects, median age was 33 years (Q1, Q3: 27 years, 37 years); 40% were White, 24% were Black, and 48% were Hispanic or Latino.

A total of 9 subjects (36%) were on high-flow oxygen; 12 subjects (48%) were on low-flow oxygen; and 1 subject (4%) was on room air, at baseline. Three subjects (12%) did not have data available on baseline oxygen status. The overall median (Q1, Q3) duration of symptoms prior to hospitalization was 7 (6, 9) days.

The overall median (Q1, Q3) duration of symptoms prior to first dose of VEKLURY was 8 (6, 9) days. Of the 25 pregnant subjects, median gestational age was 28 weeks at baseline (range 22 to 33 weeks) and about half of subjects were in each of the second and third trimester of pregnancy. No clinically relevant differences in the pharmacokinetics of remdesivir or its metabolites (GS-704277 and GS-441524) were observed between pregnant (n=21) and non-pregnant (n=22) individuals [see Clinical Pharmacology (12.3) ] .

No difference in pharmacokinetics of remdesivir or its metabolites is expected between the first and second/third trimesters. The adverse reactions observed were consistent w…

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of VEKLURY for the treatment of COVID-19 have been established in pediatric patients from birth to less than 18 years of age and weighing at least 1.5 kg, who are: 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. Use in this age group is supported by the following: Trials in adults [see Clinical Studies (14.1 , 14.2 , 14.3 , 14.4 , 14.5) ] An open-label trial (Study 5823) in 58 hospitalized pediatric subjects [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14.6) ].

Use of VEKLURY in pediatric patients from birth to less than 18 years of age and weighing at least 1.5 kg is supported by Study 5823 where 58 hospitalized pediatric subjects were treated with weight-based VEKLURY for up to 10 days in the following cohorts: Cohorts 1–4, 8; infants, children, and adolescents: Subjects ≥12 years and weighing ≥40 kg (n=12); subjects <12 years and weighing ≥40 kg (n=5); subjects ≥28 days and weighing ≥20 to <40 kg (n=12); subjects ≥28 days and weighing ≥12 to <20 kg (n=12); and subjects ≥28 days and weighing ≥3 to <12 kg (n=12); Cohorts 5–7; neonates and infants: Subjects 14 to <28 days old, GA >37 weeks, and weighing ≥2.5 kg (n=3); subjects <14 days old, GA >37 weeks, and weighing ≥2.5 kg at birth (n=1); and subjects <56 days old, GA ≤37 weeks, and weighing ≥1.5 kg at birth (n=1).

The safety and pharmacokinetic results in pediatric subjects were similar to those in adults [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , Clinical Studies (14.6) ]. Use of VEKLURY in pediatric patients weighing at least 40 kg is further supported by a clinical trial of VEKLURY in non-hospitalized subjects that included 3 pediatric subjects 12 years and older, and by clinical trials in hospitalized subjects that included 30 adult subjects weighing 40 to 50 kg. The safety in this weight group was comparable to adult subjects weighing greater than 50 kg.

Thirty-nine pediatric patients 12 years and older and weighing at least 40 kg received VEKLURY in a compassionate use program in hospitalized subjects; the available clinical data from these patients are limited [see Adverse Reactions (6.1) and Clinical Studies (14) ]. Use of VEKLURY in pediatric patients with renal impairment is supported by safety data in adults [see Adverse Reactions (6.1) , Use in Specific Populations (8.6) ]. Limited data are available regarding the safety of VEKLURY in pediatric patients with mild or moderate renal impairment.

No data are available regarding the safety of VEKLURY in pediatric patients with severe renal impairment . In adults with severe renal impairment, including those requiring dialysis, exposures of GS-441524 and GS-704277, the metabolites of remdesivir, and betadex sulfobutyl ether sodium (SBECD) are increased [see Clinical Pharmacology (12.3) ] . VEKLURY contains SBECD which, when administered intravenously, is eliminated through glomerular filtration and therefore when administered to pediatric patients with renal immaturity or renal impairment, may result in higher exposure to SBECD.

The safety and effectiveness of VEKLURY have not been established in pediatric patients weighing less than 1.5 kg.

🧓 Geriatric Use 144 words ▾

8.5Geriatric Use Of the 1,062 hospitalized subjects with SARS-CoV-2 infection randomized in ACTT-1, 36% were 65 years or older. Of the 397 hospitalized subjects with SARS-CoV-2 infection randomized in Study GS-US-540-5773, 42% were 65 years or older. Of the 584 hospitalized subjects with SARS-CoV-2 infection randomized in Study GS-US-540-5774, 27% were 65 years or older.

Of the 562 non-hospitalized subjects with SARS-CoV-2 infection randomized in Study GS-US-540-9012, 17% were 65 years or older. Reported clinical experience has not identified differences in responses between the elderly and younger patients [see Clinical Studies (14) ] . No dosage adjustment is required in patients over the age of 65 years.

In general, appropriate caution should be exercised in the administration of VEKLURY and monitoring of elderly patients, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 46 words ▾

10 OVERDOSAGE There is no human experience of acute overdosage with VEKLURY. Treatment of overdose with VEKLURY should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. There is no specific antidote for overdose with VEKLURY.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Remdesivir is an antiviral drug with activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) [see Microbiology (12.4) ].

12.2Pharmacodynamics Exposure-Response Remdesivir and metabolites exposure-response relationships and the time course of pharmacodynamics response are unknown. Cardiac Electrophysiology At 3 times the maximum recommended dose, clinically significant QTc interval prolongation was not observed.

12.3Pharmacokinetics The pharmacokinetic (PK) properties of remdesivir and metabolites are provided in Table 12. The multiple dose PK parameters of remdesivir and metabolites in adults with COVID-19 are provided in Table 13. Table 12 Pharmacokinetic Properties of Remdesivir and Metabolites (GS-441524 and GS-704277) Remdesivir GS-441524 GS-704277 ND=not detected Absorption T max (h) Remdesivir administered as a 30-minute IV infusion (Study GS-US-399-5505); range of median observed on Day 1 and Day 5 or 10.

0.67–0.68 1.51–2.00 0.75–0.75 Distribution % bound to human plasma proteins 88–93.6 Range of protein binding for remdesivir from 2 independent experiments show no evidence of concentration-dependent protein binding for remdesivir. 2 1 Blood-to-plasma ratio 0.68–1.0 1.19

0.56Elimination t 1/2 (h) Median (Study GS-US-399-4231). 1 27

1.3Metabolism Metabolic pathway(s) CES1 (80%) Cathepsin A (10%) CYP3A (10%) Not significantly metabolized HINT1 Excretion Major route of elimination Metabolism Glomerular filtration and active tubular secretion Metabolism % of dose excreted in urine Mean (Study GS-US-399-4231). 10 49 2.9 % of dose excreted in feces ND

0.5ND Table 13 Multiple Dose PK Parameters Population PK estimates for 30-minute IV infusion of remdesivir for 3 days (Study GS-US-540-9012, n=147). of Remdesivir and Metabolites (GS-441524 and GS-704277) Following IV Administration of VEKLURY 100 mg to Adults with COVID-19 Parameter Mean Geometric mean estimates. (95% CI) Remdesivir GS-441524 GS-704277 CI=Confidence Interval; ND=Not detectable (at 24 hours post-dose) C max (nanogram per mL) 2700 (2440, 2990) 143 (135, 152) 198 (180, 218) AUC tau (nanogram∙h per mL) 1710 (1480, 1980) 2410 (2250, 2580) 392 (348, 442) C trough (nanogram per mL) ND 61.5 (56.5, 66.8) ND Specific Populations Pharmacokinetic differences based on sex, race, age, and renal function on the exposures of remdesivir were evaluated using population pharmacokinetic analysis.

Sex and race did not affect the pharmacokinetics of remdesivir and its metabolites (GS-441524 and GS-704277). Pregnant Individuals The pharmacokinetics of remdesivir and its circulating metabolites (GS-441524 and GS-704277) were evaluated in pregnant individuals with COVID-19. Exposures (AUC tau , C max , and C tau ) of remdesivir and its circulating metabolites during pregnancy were similar to those in non-pregnant individuals (see Table 14 ).

Table 14 Multiple Dose PK Parameters Study CO-US-590-5961 (IMPAACT). of Remdesivir and Metabolites (GS-441524 and GS-704277) Following Intravenous Administration of VEKLURY to Pregnant and Non-Pregnant Individuals with COVID-19 Parameter Mean Geometric mean estimates. (90% CI) Pregnant Individuals (N=21) Non-Pregnant Individuals (N=22) CI=Confidence Interval Remdesivir C max (nanogram per mL) 1360 (978, 1890) 1240 (891, 1720) AUC tau (nanogram∙h per mL) 1250 (916, 1700) N=18 1300 (1070, 1590) N=17 GS-441524 C max (nanogram per mL) 113 (102, 126) 121 (108, 136) AUC tau (nanogram∙h per mL) 1840 (1630, 2070) N=20 2050 (1780, 2350) N=21 C tau (nanogram per mL) 51.6 (44.7, 59.6) 57.1 (48.7, 66.9) GS-704277 C max (nanogram per mL) 217 (187, 252) 213 (188, 240) AUC tau (nanogram∙h per mL) 454 (406, 508) 437 (384, 497) Patients with Renal Impairment The pharmacokinetics of remdesivir and its metabolites (GS-441524 and GS-704277) and excipient SBECD were evaluated in healthy subjects, those with mild (eGFR 60–89 mL/minute/1.73m 2 ), moderate (eGFR 30–59 mL/minute/1.73m 2 ), severe…

🧬 Mechanism of Action 23 words ▾

12.1Mechanism of Action Remdesivir is an antiviral drug with activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) [see Microbiology (12.4) ].

📦 How Supplied / Storage and Handling 164 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied VEKLURY for injection, 100 mg (NDC 61958-2901-2) is supplied as a single-dose vial containing a sterile, preservative-free white to off-white to yellow lyophilized powder. It requires reconstitution and further dilution prior to administration by intravenous infusion [see Dosage and Administration (2.5) ] . Discard unused portion.

The container closure is not made with natural rubber latex. Storage and Handling These products contain no preservative; therefore, partially used vials should be discarded [see Dosage and Administration (2.6) ] . Store VEKLURY for injection, 100 mg vials below 30°C (below 86°F) until required for use.

After reconstitution, use vials immediately to prepare diluted solution. Dilute the reconstituted solution in 0.9% sodium chloride injection, USP within the same day as administration. The diluted VEKLURY solution in the infusion bags can be stored up to 24 hours at room temperature (20°C to 25°C [68°F to 77°F]) prior to administration or 48 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]).

📦 Storage and Handling 101 words ▾

Storage and Handling These products contain no preservative; therefore, partially used vials should be discarded [see Dosage and Administration (2.6) ] . Store VEKLURY for injection, 100 mg vials below 30°C (below 86°F) until required for use. After reconstitution, use vials immediately to prepare diluted solution.

Dilute the reconstituted solution in 0.9% sodium chloride injection, USP within the same day as administration. The diluted VEKLURY solution in the infusion bags can be stored up to 24 hours at room temperature (20°C to 25°C [68°F to 77°F]) prior to administration or 48 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]).

📋 Description 123 words ▾

11 DESCRIPTION VEKLURY contains remdesivir, a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor. The chemical name for remdesivir is 2-ethylbutyl N -{( S )-[2- C -(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-2,5-anhydro-d-altrononitril-6- O -yl]phenoxyphosphoryl}-L-alaninate. It has a molecular formula of C 27 H 35 N 6 O 8 P and a molecular weight of 602.6 g/mol.

Remdesivir has the following structural formula: VEKLURY for injection contains 100 mg of remdesivir as a sterile, preservative-free lyophilized white to off-white to yellow powder in a single-dose clear glass vial. It requires reconstitution and then further dilution prior to administration by intravenous infusion [see Dosage and Administration (2.5) ] . The inactive ingredients are 3 g betadex sulfobutyl ether sodium and may include hydrochloric acid and/or sodium hydroxide for pH adjustment.

Chemical Structure

💬 Information for Patients 185 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Hypersensitivity Reactions Inform patients that hypersensitivity reactions have been seen in patients receiving VEKLURY during and after infusion. Advise patients to inform their healthcare provider if they experience any of the following: changes in heart rate; fever; shortness of breath, wheezing; swelling of the lips, face, or throat; rash; nausea; sweating; or shivering [see Warnings and Precautions (5.1) ].

Increased Risk of Transaminase Elevations Inform patients that VEKLURY may increase the risk of hepatic laboratory abnormalities. Advise patients to alert their healthcare provider immediately if they experience any symptoms of liver inflammation [see Warnings and Precaution (5.2) ]. Drug Interactions Inform patients that VEKLURY may interact with other drugs.

Advise patients to report to their healthcare provider the use of any other prescription or nonprescription medication or herbal products, including chloroquine phosphate or hydroxychloroquine sulfate [see Warnings and Precautions (5.3) , Drug Interactions (7) , and Microbiology (12.4) ]. Pregnancy Inform patients to notify their healthcare provider in the event of a pregnancy [see Use in Specific Populations (8.1) ].

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.