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VERQUVO vericiguat 5 mg Tablet, Film Coated, 14-count — NDC 00006-5029-05 package photo

VERQUVO vericiguat 5 mg Tablet, Film Coated, 14-count

by Merck Sharp & Dohme LLC · 14 TABLET, FILM COATED in 1 BOTTLE (0006-5029-05)
NDC 00006-5029-05
🏷️ FDA NDC (as labeled) 0006-5029-05 billing pads the labeler segment with a zero
This package
Contains14-count Pack sizes5 compare ↓
Also comes in: 10 tablets 00006-5029-04 14 tablets 00006-5029-01 14 tablets 00006-5029-06 30 tablets 00006-5029-02
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 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

🆔 Identity & classification

FDA NDC (as labeled) 0006-5029-05
Product NDC 0006-5029
11-digit billing NDC 00006502905
RxCUI 2475846, 2475852, 2475854, 2475856, 2475858, 2475860
UNII LV66ADM269
UPC 0300065029023, 0300065030012, 0300065028026
Application # NDA214377
SPL Set ID 17056d73-1b1b-4bf2-9c07-b7a9367f0d6d
Established class (EPC) Soluble Guanylate Cyclase Stimulator
Mechanism of action Guanylate Cyclase Stimulators
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-02-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance VERICIGUAT
GPI-14 40900085000330
GPI class Verquvo
Why two NDCs? The FDA registers this code as 0006-5029-05 — a 4-4-2 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 labeler segment → 00006-5029-05. 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 Soluble Guanylate Cyclase Stimulator class.

Pharmacologic class Soluble Guanylate Cyclase Stimulator
Drug family (ATC) Other vasodilators used in cardiac diseases
How it works Guanylate Cyclase Stimulators
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

LabelerMerck Sharp & Dohme LLC
Application holderMERCK SHARP AND DOHME LLC
FDA applicationNDA214377 (NDA)
Labeler code00006
First marketedFeb 2021
Product typeHuman Prescription Drug
Portfolio112 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

📗 Our plain-language guide HelloPharmacist
  • Verquvo is designed to lower your chances of dying from a heart-related cause or ending up back in the hospital because of your heart failure. It doesn't cure heart failure, but in...
  • What exactly is Verquvo supposed to do for me?
  • Yes — this one actually matters. Taking Verquvo with food significantly increases how much of the drug your body absorbs and makes your blood levels more predictable from day to da...
  • The two most common ones are low blood pressure and anemia (a drop in red blood cells). Low blood pressure can make you feel dizzy, lightheaded, or like you might faint — especiall...
📖 Read our full Vericiguat 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.

💊 What it looks like

Color White / Brown / Yellow
ShapeRound
Imprint10;VC
Size9 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII R75537T0T4
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

9 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 eachPer 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: 10 tablets 14 tablets 14 tablets 30 tablets
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
Verquvo 5 mgthis 00006-5029-05 Merck 14 tablets — — FDA listed —
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

🏛️
2021
First FDA approval
Jan 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2032
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 2032. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jan 19, 2021 RLD RS ⏳ ~6.2 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 9993476 — method of use (U-3062)
US 8921377 — method of use (U-3062)
US 9604948 — drug substance (U-3062)
US 8921377 — method of use (U-3062)
US 9993476 — method of use (U-3062)
US 9604948 — drug substance (U-3062)
US 9993476 — method of use (U-3062)
US 8921377 — method of use (U-3062)
US 9604948 — drug substance (U-3062)
US 11439642 — method of use (U-3062)
US 11439642 — method of use (U-3062)
US 11439642 — method of use (U-3062)
US 10736896 — drug substance
US 10736896 — drug substance
US 10736896 — drug substance
US 8420656 — drug substance
US 8420656 — drug substance
US 8420656 — drug substance
Exclusivity D-198
Exclusivity NCE
Exclusivity D-198
Exclusivity NCE
Exclusivity D-198
Exclusivity NCE
2021 2023 2025 2027 2029 2031 2033
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 (18)
PatentTypeUse codeExpires
US 9993476 ↗ Method of use U-3062 May 19, 2031
US 8921377 ↗ Method of use U-3062 May 19, 2031
US 9604948 ↗ Drug substance U-3062 Nov 26, 2032
US 8921377 ↗ Method of use U-3062 May 19, 2031
US 9993476 ↗ Method of use U-3062 May 19, 2031
US 9604948 ↗ Drug substance U-3062 Nov 26, 2032
US 9993476 ↗ Method of use U-3062 May 19, 2031
US 8921377 ↗ Method of use U-3062 May 19, 2031
US 9604948 ↗ Drug substance U-3062 Nov 26, 2032
US 11439642 ↗ Method of use U-3062 May 19, 2031
US 11439642 ↗ Method of use U-3062 May 19, 2031
US 11439642 ↗ Method of use U-3062 May 19, 2031
US 10736896 ↗ Drug substance — May 19, 2031
US 10736896 ↗ Drug substance — May 19, 2031
US 10736896 ↗ Drug substance — May 19, 2031
US 8420656 ↗ Drug substance — May 19, 2031
US 8420656 ↗ Drug substance — May 19, 2031
US 8420656 ↗ Drug substance — May 19, 2031
FDA exclusivity
CodeWhat it grantsExpires
D-198Other change requiring clinical data (3-year)Jan 21, 2029
NCENew Chemical Entity (5-year)Jan 19, 2026
D-198Other change requiring clinical data (3-year)Jan 21, 2029
NCENew Chemical Entity (5-year)Jan 19, 2026
D-198Other change requiring clinical data (3-year)Jan 21, 2029
NCENew Chemical Entity (5-year)Jan 19, 2026
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Nov 2032 — 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.
30 tablets00006-5029-02 1,435 Rx · $1,287,099
14 tablets00006-5029-01 681 Rx · $593,448
10 tablets00006-5029-04 No Medicaid data
14 tablets this page00006-5029-05 No Medicaid data
14 tablets00006-5029-06 No Medicaid data
Drug total (last 4 qtrs): 2,116 Rx · 83,606 units · $1,880,547 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 Verquvo — 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 Verquvo. 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
$16.14M
Claims incl. refills
14.6K
Beneficiaries
8.6K
Spend / beneficiary
$1,883.12
Spend / claim
$1,105.53
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 VERQUVO (this brand).

Top reported reactions

Hypotension111
Death95
Cardiac Failure72
Dizziness68
Anaemia40
Blood Pressure Decreased40
Fatigue37

Age at onset

Adult35
Elderly114

Reporter sex

966 reports
Male · 66%
Female · 34%
Unknown · 0%

Serious outcomes

Life-threatening32
Disabling5
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 218 58
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 Per unit Per pack Marketing startStatus
00006-5029-01 14 TABLET, FILM COATED in 1 BOTTLE (0006-5029-01) $22.72 / ea $318.10 2021-02-01 Active
00006-5029-02 30 TABLET, FILM COATED in 1 BOTTLE (0006-5029-02) $22.72 / ea $681.64 2021-02-01 Active
00006-5029-04 10 BLISTER PACK in 1 CARTON (0006-5029-04) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0006-5029-03) $22.72 / ea $2,272.14 2021-02-01 Active
00006-5029-05 You're viewing this 14 TABLET, FILM COATED in 1 BOTTLE (0006-5029-05) — — 2021-02-01 Active
00006-5029-06 1 BOTTLE in 1 CARTON (0006-5029-06) / 14 TABLET, FILM COATED in 1 BOTTLE (0006-5029-05) — — 2021-02-01 Active

This pack shows little to no recent Medicaid volume — the 30 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 00006-5029-05?
NDC 00006-5029-05 is a 14-count package — 14 tablet, film coated in 1 bottle.
What is the difference between NDC 00006-5029-05 and NDC 00006-5029-01?
Both are VERQUVO vericiguat 5 mg Tablet, Film Coated — the drug itself is identical. NDC 00006-5029-05 is the 14-count package, while NDC 00006-5029-01 is the 14 tablets package.
What NDC number is used to bill for this package of VERQUVO vericiguat 5 mg Tablet, Film Coated?
Bill NDC 00006-5029-05 — the 11-digit billing format is 00006502905. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

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.
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 0006-5029-05, 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: 00006-5029-05, written without dashes as 00006502905. 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 00006-5029-05, the first segment (00006) is the labeler code FDA assigned to Merck Sharp & Dohme LLC; the middle segment (5029) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Merck Sharp & Dohme LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 10 tablets (00006-5029-04), 14 tablets (00006-5029-01), 14 tablets (00006-5029-06). 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?
Merck Sharp & Dohme LLC 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.
🚨 Boxed Warning 🎯 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 💬 Medication Guide
🚨 Boxed Warning 141 words ▾

WARNING: EMBRYO-FETAL TOXICITY Females of reproductive potential: Exclude pregnancy before the start of treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment. Do not administer VERQUVO to a pregnant female because it may cause fetal harm [see Dosage and Administration (2.2) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.3) ] .

WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Do not administer VERQUVO to a pregnant female because it may cause fetal harm. ( 4 , 5.1 , 8.1 ) Females of reproductive potential: Exclude pregnancy before the start of treatment.

To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment. ( 2.2 , 5.1 , 8.3 )

🎯 Indications and Usage 98 words ▾

1 INDICATIONS AND USAGE VERQUVO ® is indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45% [see Clinical Studies (14) ] . VERQUVO is a soluble guanylate cyclase (sGC) stimulator, indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%.

( 1 )

⏱️ Dosage and Administration 214 words ▾

2 DOSAGE AND ADMINISTRATION The recommended starting dose of VERQUVO is 5 mg orally once daily with food. ( 2.1 ) For patients at risk of symptomatic hypotension, the recommended starting dose is 2.5 mg orally once daily with food. ( 2.1 ) Double the dose after approximately every 2 weeks to reach the target maintenance dose of 10 mg once daily, as tolerated by the patient.

( 2.1 ) Tablets may be crushed and mixed with water for patients unable to swallow whole tablets. ( 2.1 )

2.1Recommended Dosage The recommended starting dose of VERQUVO is 5 mg orally once daily with food. For patients at risk of symptomatic hypotension, the recommended starting dose is 2.5 mg orally once daily with food [see Clinical Trials Experience (6.1) ]. Double the dose approximately every 2 weeks to reach the target maintenance dose of 10 mg once daily, as tolerated by the patient.

For patients who are unable to swallow whole tablets, VERQUVO may be crushed and mixed with water immediately before administration [see Clinical Pharmacology (12.3) ] .

2.2Pregnancy Testing in Females of Reproductive Potential Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with VERQUVO [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ].

💊 Dosage Forms and Strengths 88 words ▾

3 DOSAGE FORMS AND STRENGTHS VERQUVO 2.5 mg (vericiguat 2.5 mg) are round, biconvex, white film-coated tablets debossed with “2.5” on one side and “VC” on the other side. VERQUVO 5 mg (vericiguat 5 mg) are round, biconvex, brown-red film-coated tablets debossed with “5” on one side and “VC” on the other side. VERQUVO 10 mg (vericiguat 10 mg) are round, biconvex, yellow-orange film-coated tablets debossed with “10” on one side and “VC” on the other side.

Tablets: 2.5 mg, 5 mg and 10 mg ( 3 )

⛔ Contraindications 60 words ▾

4 CONTRAINDICATIONS VERQUVO is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators [see Drug Interactions (7.1) ] . VERQUVO is contraindicated in pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators. ( 4 , 7.1 ) Pregnancy ( 4 )

⚠️ Warnings and Cautions 83 words ▾

5 WARNINGS AND PRECAUTIONS

5.1Embryo-Fetal Toxicity Based on data from animal reproduction studies, VERQUVO may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Obtain a pregnancy test before the start of treatment.

Advise females of reproductive potential to use effective contraception during treatment with VERQUVO and for at least one month after the final dose [see Dosage and Administration (2.2) and Use in Specific Populations (8.1 , 8.3) ].

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions reported in ≥5% are hypotension and anemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 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. VERQUVO was evaluated in VICTORIA, which included 2,519 patients treated with VERQUVO (up to 10 mg once daily). The mean duration of VERQUVO exposure was 1 year, and the maximum duration was 2.6 years [see Clinical Studies (14) ] .

Table 1 lists adverse drug reactions occurring more commonly with VERQUVO than placebo and in ≥5% of patients treated with VERQUVO in VICTORIA. Table 1: Adverse Drug Reactions Occurring with VERQUVO in VICTORIA Adverse Drug Reaction VERQUVO % N = 2,519 Placebo % N = 2,515 Hypotension 16 15 Anemia 10 7 VELOCITY The safety and tolerability of VERQUVO 5 mg once daily as a starting dose was evaluated in VELOCITY, a single-arm, open-label, 2-week study in 106 patients with symptomatic chronic heart failure (NYHA class II–IV) and left ventricular ejection fraction < 45%.

Patients were excluded from the study if they experienced symptomatic hypotension within 4 weeks before screening. Treatment initiation with VERQUVO 5 mg once daily in VELOCITY was similarly tolerated as treatment initiation of 2.5 mg once daily in the VICTORIA study.

🔄 Drug Interactions 64 words ▾

7 DRUG INTERACTIONS PDE-5 Inhibitors: Concomitant use is not recommended. ( 7.2 )

7.1Other Soluble Guanylate Cyclase Stimulators VERQUVO is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators [see Contraindications (4) ] .

7.2PDE-5 Inhibitors Concomitant use of VERQUVO with PDE-5 inhibitors is not recommended because of the potential for hypotension [see Clinical Pharmacology (12.2) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not recommended ( 8.2 )

8.1Pregnancy Pregnancy Surveillance Program There is a Pregnancy Surveillance Program that monitors pregnancy outcomes in women exposed to VERQUVO during pregnancy. Health care providers should report any prenatal exposure to VERQUVO by calling 1-877-888-4231 or at https://pregnancyreporting.verquvo-us.com. Risk Summary Based on data from animal reproduction studies, VERQUVO may cause fetal harm when administered to a pregnant woman and is contraindicated during pregnancy [see Contraindications (4) ] .

There are no available data with VERQUVO use in pregnant women. In animal reproduction studies, oral administration of vericiguat to pregnant rabbits during organogenesis, at ≥4 times the human exposure (total AUC) with the maximum recommended human dose (MRHD) of 10 mg, resulted in malformations of the heart and major vessels, as well as increased number of abortions and resorptions ( see Animal Data ). In a pre/postnatal toxicity study, vericiguat administered orally to rats during gestation through lactation caused maternal toxicity, which resulted in decreased pup body weight gain (≥10 times the MRHD) and increased pup mortality (24 times the MRHD) during the preweaning period (see Animal Data ) .

The estimated 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 2-4% and 15-20%, respectively.

Data Animal Data In an embryo-fetal development study in rabbits, vericiguat was administered orally to pregnant rabbits during the period of organogenesis from gestation day (GD) 6 to 20 at doses of 0.75, 2.5 or 7.5 mg/kg/day. An increased incidence of cardiac ventricular septal defect along with truncus arteriosus communis was observed at ≥2.5 mg/kg/day, which is ≥4 times the human exposure at the MRHD. Maternal toxicity (decreased food consumption and body weight loss), which may have resulted in late spontaneous abortions and resorptions was noted at ≥2.5 mg/kg/day (≥4 times the human exposure at the MRHD).

There were no maternal toxicity or abortions/resorptions and no malformations of the heart and major vessels in rabbits at an exposure approximately equivalent to the human exposure at the MRHD. In a prenatal developmental toxicity study in rats, vericiguat was administered orally to pregnant rats during the period of organogenesis from GD 6 to 17 at doses of 5, 15 or 50 mg/kg/day. No developmental toxicity was observed up to the highest dose (36 times the human exposure [total AUC] at the MRHD).

Maternal toxicity (decreased body weight gain and food consumption) was observed at ≥15 mg/kg/day (≥10 times the human exposure at the MRHD). There was no maternal toxicity at 5 mg/kg/day (4 times the human exposure at the MRHD). In a pre-postnatal development study in rats, vericiguat was administered orally at doses of 7.5, 15 or 30 mg/kg/day from GD 6 through lactation day 21.

Maternal toxicity (decreases in food consumption and body weight gain) was observed at all dose levels ≥6 times the human exposure (total AUC) at the MRHD and resulted in decreased pup body weight gain at ≥15 mg/kg/day (≥10 times the human exposure at the MRHD) and pup mortality at 30 mg/kg/day (24 times the MRHD). [ 14 C]-vericiguat was administered orally to pregnant rats at a dose of 3 mg/kg. Vericiguat-related material was transferred across the placenta, with fetal plasma concentrations of approximately 67% maternal concentrations on GD 19.

8.2Lactation Risk Summary There are no data on the presence of vericiguat in human milk, the effects on the breastfed infant, or the effects on milk production. Vericiguat is present in the milk of lactating rats and it is likely that vericiguat or its metabolites are p…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Surveillance Program There is a Pregnancy Surveillance Program that monitors pregnancy outcomes in women exposed to VERQUVO during pregnancy. Health care providers should report any prenatal exposure to VERQUVO by calling 1-877-888-4231 or at https://pregnancyreporting.verquvo-us.com. Risk Summary Based on data from animal reproduction studies, VERQUVO may cause fetal harm when administered to a pregnant woman and is contraindicated during pregnancy [see Contraindications (4) ] .

There are no available data with VERQUVO use in pregnant women. In animal reproduction studies, oral administration of vericiguat to pregnant rabbits during organogenesis, at ≥4 times the human exposure (total AUC) with the maximum recommended human dose (MRHD) of 10 mg, resulted in malformations of the heart and major vessels, as well as increased number of abortions and resorptions ( see Animal Data ). In a pre/postnatal toxicity study, vericiguat administered orally to rats during gestation through lactation caused maternal toxicity, which resulted in decreased pup body weight gain (≥10 times the MRHD) and increased pup mortality (24 times the MRHD) during the preweaning period (see Animal Data ) .

The estimated 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 2-4% and 15-20%, respectively.

Data Animal Data In an embryo-fetal development study in rabbits, vericiguat was administered orally to pregnant rabbits during the period of organogenesis from gestation day (GD) 6 to 20 at doses of 0.75, 2.5 or 7.5 mg/kg/day. An increased incidence of cardiac ventricular septal defect along with truncus arteriosus communis was observed at ≥2.5 mg/kg/day, which is ≥4 times the human exposure at the MRHD. Maternal toxicity (decreased food consumption and body weight loss), which may have resulted in late spontaneous abortions and resorptions was noted at ≥2.5 mg/kg/day (≥4 times the human exposure at the MRHD).

There were no maternal toxicity or abortions/resorptions and no malformations of the heart and major vessels in rabbits at an exposure approximately equivalent to the human exposure at the MRHD. In a prenatal developmental toxicity study in rats, vericiguat was administered orally to pregnant rats during the period of organogenesis from GD 6 to 17 at doses of 5, 15 or 50 mg/kg/day. No developmental toxicity was observed up to the highest dose (36 times the human exposure [total AUC] at the MRHD).

Maternal toxicity (decreased body weight gain and food consumption) was observed at ≥15 mg/kg/day (≥10 times the human exposure at the MRHD). There was no maternal toxicity at 5 mg/kg/day (4 times the human exposure at the MRHD). In a pre-postnatal development study in rats, vericiguat was administered orally at doses of 7.5, 15 or 30 mg/kg/day from GD 6 through lactation day 21.

Maternal toxicity (decreases in food consumption and body weight gain) was observed at all dose levels ≥6 times the human exposure (total AUC) at the MRHD and resulted in decreased pup body weight gain at ≥15 mg/kg/day (≥10 times the human exposure at the MRHD) and pup mortality at 30 mg/kg/day (24 times the MRHD). [ 14 C]-vericiguat was administered orally to pregnant rats at a dose of 3 mg/kg. Vericiguat-related material was transferred across the placenta, with fetal plasma concentrations of approximately 67% maternal concentrations on GD 19.

🧒 Pediatric Use 15 words ▾

8.4Pediatric Use Safety and effectiveness of VERQUVO have not been established in pediatric patients.

🧓 Geriatric Use 84 words ▾

8.5Geriatric Use No dosage adjustment of VERQUVO is required in geriatric patients. In VICTORIA, a total of 1,596 (63%) patients treated with VERQUVO were 65 years and older, and 783 (31%) patients treated with VERQUVO were 75 years and older. No overall differences in safety or efficacy of VERQUVO were observed between patients aged 65 years and older compared to younger patients, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology (12.3) and Clinical Studies (14) ] .

🆘 Overdosage 83 words ▾

10 OVERDOSAGE Limited data are available with regard to overdosage in human patients treated with VERQUVO. In VICTORIA, doses up to 10 mg have been studied. In a study of patients with preserved ejection fraction heart failure (left ventricular ejection fraction ≥45%), multiple doses of VERQUVO 15 mg have been studied and were generally well tolerated.

In the event of an overdose, hypotension may result. Symptomatic treatment should be provided. VERQUVO is unlikely to be removed by hemodialysis because of high protein binding.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Vericiguat is a stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signaling pathway. When NO binds to sGC, the enzyme catalyzes the synthesis of intracellular cyclic guanosine monophosphate (cGMP), a second messenger that plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling. Heart failure is associated with impaired synthesis of NO and decreased activity of sGC, which may contribute to myocardial and vascular dysfunction.

By directly stimulating sGC, independently of and synergistically with NO, vericiguat augments levels of intracellular cGMP, leading to smooth muscle relaxation and vasodilation.

12.2Pharmacodynamics The mean reduction in systolic blood pressure was approximately 1 to 2 mm Hg greater in patients who received VERQUVO compared with placebo. VERQUVO demonstrated a dose-dependent reduction in NT-proBNP, a biomarker in heart failure, at 12 weeks compared to placebo when added to standard of care. The estimated reduction from baseline NT-proBNP at week 32 was greater in patients who received VERQUVO compared with placebo [see Clinical Studies (14) ] .

Cardiac Electrophysiology There was no evidence of proarrhythmic risk in an in vitro assessment of vericiguat or its major N-glucuronide metabolite. No inhibition of cardiac ion channels (hERG, hNav1.5, or hKvLQT1/mink) was observed at substantial multiples of their unbound C max values at the recommended target dose of 10 mg. The integrated risk assessment of nonclinical and clinical data supports that administration of vericiguat 10 mg is not associated with clinically meaningful QTc prolongation.

Drug Interaction Studies No clinically significant differences on bleeding time or platelet aggregation were observed when a single dose of vericiguat 15 mg was used concomitantly with 500 mg of aspirin. No clinically significant differences in prothrombin time or the activities of Factors II, VII, and X were observed when multiple doses of VERQUVO 10 mg once daily were used concomitantly with a single dose of warfarin 25 mg. No clinically significant differences on seated blood pressure (BP) were observed when multiple doses of VERQUVO 2.5 mg were used concomitantly with sacubitril/valsartan in healthy subjects.

No clinically significant differences on seated BP were observed when multiple doses of VERQUVO 10 mg were used concomitantly with short- and long-acting nitrates (nitroglycerin spray and isosorbide mononitrate [ISMN] modified release 60 mg) in patients with coronary artery disease. In patients with heart failure, concomitant use with short-acting nitrates was well tolerated, but there is limited experience with long-acting nitrates. Concomitant use of VERQUVO 10 mg with single doses of sildenafil (25, 50, or 100 mg) was associated with additional seated BP reduction of up to 5.4 mm Hg (systolic/diastolic BP, MAP), compared to administration of VERQUVO alone.

There is limited experience with concomitant use of VERQUVO and PDE-5 inhibitors in patients with heart failure.

12.3Pharmacokinetics Vericiguat steady-state mean (coefficient of variation %) C max is 350 mcg/L (29%) and AUC is 6,680 mcg•h/L (33.9%) following administration of VERQUVO 10 mg in patients with heart failure. Vericiguat pharmacokinetics increases in a slightly less than dose-proportional manner. Vericiguat accumulates in plasma up to 155-171% and reaches steady-state after approximately 6 days.

Absorption The absolute bioavailability of vericiguat is 93% when taken with food. Results were comparable when VERQUVO was administered orally as a whole tablet or as a crushed tablet in water. Effect of Food Administration of VERQUVO 10 mg with a high-fat, high-calorie meal increases T max from about 1 hour (fasted) to about 4 hours (fed), reduces PK variability, and increases vericiguat AUC by 44% and C max by 41% compared with administration in the fasted state.

Simila…

🧬 Mechanism of Action 102 words ▾

12.1Mechanism of Action Vericiguat is a stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signaling pathway. When NO binds to sGC, the enzyme catalyzes the synthesis of intracellular cyclic guanosine monophosphate (cGMP), a second messenger that plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling. Heart failure is associated with impaired synthesis of NO and decreased activity of sGC, which may contribute to myocardial and vascular dysfunction.

By directly stimulating sGC, independently of and synergistically with NO, vericiguat augments levels of intracellular cGMP, leading to smooth muscle relaxation and vasodilation.

📦 How Supplied / Storage and Handling 159 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied VERQUVO (vericiguat) is available as round, film-coated, biconvex tablets in the following configurations: Strength Color Markings (debossed) Obverse/Reverse NDC # 14 Count Bottle 30 Count Bottle 90 Count Bottle Carton/100 10 blister cards of 10 tablets 2.5 mg White "2.5"/"VC" 0006-5028-01 0006-5028-02 - 0006-5028-04 5 mg Brown-Red "5"/"VC" 0006-5029-01 0006-5029-02 - 0006-5029-04 10 mg Yellow-Orange "10"/"VC" - 0006-5030-01 0006-5030-02 0006-5030-04

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (between 59°F to 86°F). See USP for Controlled Room Temperature.

16.1How Supplied VERQUVO (vericiguat) is available as round, film-coated, biconvex tablets in the following configurations: Strength Color Markings (debossed) Obverse/Reverse NDC # 14 Count Bottle 30 Count Bottle 90 Count Bottle Carton/100 10 blister cards of 10 tablets 2.5 mg White "2.5"/"VC" 0006-5028-01 0006-5028-02 - 0006-5028-04 5 mg Brown-Red "5"/"VC" 0006-5029-01 0006-5029-02 - 0006-5029-04 10 mg Yellow-Orange "10"/"VC" - 0006-5030-01 0006-5030-02 0006-5030-04

📦 Storage and Handling 28 words ▾

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (between 59°F to 86°F). See USP for Controlled Room Temperature.

📋 Description 163 words ▾

11 DESCRIPTION VERQUVO tablets contains vericiguat, a soluble guanylate cyclase stimulator. The chemical name of vericiguat is methyl {4,6-diamino-2-[5-fluoro-1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b] pyridin-3-yl] pyrimidin-5-yl} carbamate. The molecular formula is C 19 H 16 F 2 N 8 O 2 and the molecular weight is 426.39 g/mol.

The chemical structure is: Vericiguat is a white to yellowish powder that is freely soluble in dimethyl sulfoxide; slightly soluble in acetone; very slightly soluble in ethanol, acetonitrile, methanol, and ethyl acetate; and practically insoluble in 2-propanol. VERQUVO ® is available as film-coated tablets for oral administration, containing 2.5 mg of vericiguat, 5 mg of vericiguat or 10 mg of vericiguat. The tablet inactive ingredients are croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate.

The film coating contains hypromellose, talc and titanium dioxide. The film coating for the 5 mg of VERQUVO tablet also contains ferric oxide red. The film coating for the 10 mg of VERQUVO tablet also contains ferric oxide yellow. image description

💬 Information for Patients 180 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Dosing Instructions If a dose is missed, it should be taken as soon as the patient remembers on the same day of the missed dose. Patients should not take two doses of VERQUVO on the same day.

Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy. Advise females of reproductive potential to use effective contraception during treatment with VERQUVO and for one month after the final dose [see Contraindications (4) , Warnings and Precautions (5.1) and Use in Specific Populations (8.1 , 8.3) ]. Pregnancy Advise women who are exposed to VERQUVO during pregnancy to report their pregnancy to their healthcare provider.

Health care providers should report any prenatal exposure to VERQUVO by calling 1-877-888-4231 or at https://pregnancyreporting.verquvo-us.com. [See Use in Specific Populations (8.1) ]. Lactation Advise women not to breastfeed during treatment with VERQUVO [see Use in Specific Populations (8.2) ] .

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 07/2023 MEDICATION GUIDE VERQUVO ® (ver-KYU-voh) (vericiguat) tablets What is the most important information I should know about VERQUVO? VERQUVO may cause birth defects if taken during pregnancy.

Females must not be pregnant when they start taking VERQUVO. Females who are able to get pregnant: Your healthcare provider will do a pregnancy test to make sure that you are not pregnant before you start taking VERQUVO. You must use effective forms of birth control during treatment and for 1 month after you stop treatment with VERQUVO.

Talk to your healthcare provider about forms of birth control that you may use to prevent pregnancy during treatment with VERQUVO. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with VERQUVO. There is a Pregnancy Surveillance Program that monitors pregnancy outcomes in women exposed to VERQUVO during pregnancy.

Patients should report any exposure to VERQUVO during pregnancy by calling 1-877-888-4231 or at https://pregnancyreporting.verquvo-us.com. What is VERQUVO? VERQUVO is a prescription medicine used in adults who are having symptoms of their chronic (long-lasting) heart failure, who have had a recent hospitalization or the need to receive intravenous (IV) medicines and have an ejection fraction (amount of blood pumped with each heartbeat) of less than 45 percent: to reduce the risk of dying and to reduce the need to be hospitalized Heart failure happens when your heart is weak and cannot pump enough blood to your lungs and the rest of your body.

It is not known if VERQUVO is safe and effective in children. Do not take VERQUVO if you: are taking another medicine called a soluble guanylate cyclase stimulator (sGC). Ask your healthcare provider if you are not sure if you are taking an sGC medicine. are pregnant.

See “What is the most important information I should know about VERQUVO?” Before you take VERQUVO, tell your healthcare provider about all your medical conditions, including if you: are breastfeeding or plan to breastfeed. It is not known if VERQUVO passes into your breast milk. Do not breastfeed if you take VERQUVO.

Talk with your healthcare provider about the best way to feed your baby if you take VERQUVO. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how VERQUVO works.

How should I take VERQUVO? Take VERQUVO exactly as your healthcare provider tells you to. Take VERQUVO 1 time each day with food.

Swallow VERQUVO tablets whole. If you are not able to swallow the tablet whole, you may crush VERQUVO tablets and mix with water right before taking your dose. Your healthcare provider may change your dose — when you first start taking VERQUVO to find the best dose for you and how well you tolerate VERQUVO.

If you miss a dose, take the missed dose as soon as you remember on the same day of the missed dose. Do not take 2 doses of VERQUVO on the same day to make up for a missed dose. If you take too much VERQUVO, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of VERQUVO? VERQUVO may cause serious side effects, including: See “What is the most important information I should know about VERQUVO?” The most common side effects of VERQUVO include: low blood pressure low red blood cells (anemia) These are not all the possible side effects of VERQUVO. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088. How should I store VERQUVO? Store VERQUVO at room temperature between 68°F to 77°F (20°C to 25°C).

Keep VERQUVO and all medicines out of the reach of children. General information about the safe and effective use of VERQUVO. Medicines are sometimes prescribed for purposes other than those li…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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