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Viberzi Eluxadoline 75 mg Tablet, Film Coated — NDC 61874-0075-16 package photo

Viberzi Eluxadoline 75 mg Tablet, Film Coated

by Allergan, Inc. · 2 BLISTER PACK in 1 CARTON (61874-075-16) / 8 TABLET, FILM COATED in 1 BLISTER PACK (61874-075-08)
NDC 61874-0075-16
🏷️ FDA NDC (as labeled) 61874-075-16 billing pads the product segment with a zero
This package
Contains8 tablet, film coated in 1 blister pack Pack sizes3 compare ↓
Also priced by: Part D plans $29.69/unit — full pricing hub ↓
Also comes in: 8 tablets 61874-0075-60 8 tablets 61874-0075-08
Rx only Brand On market CIV
🗂️ 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) 61874-075-16
Product NDC 61874-075
11-digit billing NDC 61874007516
RxCUI 1653786, 1653792, 1719764, 1719766
UNII 45TPJ4MBQ1
UPC 0361874075601
Application # NDA206940
SPL Set ID 7821bd40-4c84-4984-951b-6436ae20421a
Established class (EPC) mu-Opioid Receptor Agonist
Mechanism of action Opioid mu-Receptor Agonists
DEA schedule CIV
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-10-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance ELUXADOLINE
GPI-14 52558020000330
GCN Seq No 074654
GCN 39354
HICL code 042445
Ingredient (HICL) Eluxadoline
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Colon
HIC3 code D6L
Therapeutic class — specific (HIC3) Ibs Agents,Mixed Opioid Recep Agonists/Antagonists
AHFS code 56:08.00.00
AHFS class Antidiarrhea Agents
FDB label name VIBERZI 75 MG TABLET
FDB brand name Viberzi
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 61874-075-16 — a 5-3-2 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 product segment → 61874-0075-16. 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 mu-Opioid Receptor Agonist class.

Pharmacologic class mu-Opioid Receptor Agonist
Drug family (ATC) Antipropulsives
How it works Opioid mu-Receptor Agonists
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

LabelerAllergan, Inc.
Application holderABBVIE INC
FDA applicationNDA206940 (NDA)
Labeler code61874
First marketedOct 2015
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio188 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 VIBERZI 75 MG TABLET Ingredient Eluxadoline
📖 What it is MedlinePlus · NLM

Eluxadoline is used to treat irritable bowel syndrome with diarrhea (IBS-D; a condition that causes stomach pain, cramping, or loose or watery stools) in adults. Eluxadoline is in a class of medications called mu-opioid receptor agonists. It works by decreasing bowel activity.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Viberzi targets opioid receptors in your intestine — not in your brain — to help slow down gut contractions and reduce pain signals. The result is fewer episodes of diarrhea and le...
  • What exactly does Viberzi do for my IBS-D?
  • No — this is one of the most important safety points with Viberzi. If you no longer have a gallbladder, you should not take this medication at all. People without a gallbladder fac...
  • Is it safe to take Viberzi if I've had my gallbladder out?
📖 Read our full Eluxadoline 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 yellow / pink
ShapeCapsule
ImprintFX100
Size19 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 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient 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 EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • 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 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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.

11 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 · Q2 2026 $29.69 $475.01 / 16 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
Viberzi 75 mgthis 61874-0075-16 Allergan, 8 tablets — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2015
First FDA approval
May 2015
📍
2026
Currently FDA-listed
11 years listed
🛡️
2033
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Mar 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 27, 2015 RLD RS ⏳ ~6.5 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 9115091 — drug substance (U-1738)
US 9364489 — method of use (U-1709)
US 9364489 — method of use (U-1709)
US 9789125 — method of use (U-2152)
US 9789125 — method of use (U-1709)
US 9789125 — method of use (U-1709)
US 9789125 — method of use (U-2152)
US 8691860 — drug substance (U-1709)
US 8691860 — drug substance (U-1709)
US 11484527 — method of use (U-3475)
US 9115091 — drug substance (U-1738)
US 12097187 — method of use (U-3475)
US 9675587 — drug product
US 11007179 — drug product
US 11007179 — drug product
US 11090291 — drug product
US 11311516 — drug product
US 7741356 — drug substance
US 9675587 — drug product
US 11229627 — drug product
US 10188632 — drug product
US 7741356 — drug substance
US 11229627 — drug product
US 11311516 — drug product
US 11160792 — drug product
US 11160792 — drug product
US 10188632 — drug product
US 11090291 — drug product
2015 2017 2019 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 (28)
PatentTypeUse codeExpires
US 9115091 ↗ Drug substance U-1738 Jul 7, 2028
US 9364489 ↗ Method of use U-1709 Jul 7, 2028
US 9364489 ↗ Method of use U-1709 Jul 7, 2028
US 9789125 ↗ Method of use U-2152 Jul 7, 2028
US 9789125 ↗ Method of use U-1709 Jul 7, 2028
US 9789125 ↗ Method of use U-1709 Jul 7, 2028
US 9789125 ↗ Method of use U-2152 Jul 7, 2028
US 8691860 ↗ Drug substance U-1709 Jul 7, 2028
US 8691860 ↗ Drug substance U-1709 Jul 7, 2028
US 11484527 ↗ Method of use U-3475 Mar 14, 2033
US 9115091 ↗ Drug substance U-1738 Jul 7, 2028
US 12097187 ↗ Method of use U-3475 Mar 14, 2033
US 9675587 ↗ Drug product — Mar 14, 2033
US 11007179 ↗ Drug product — Mar 14, 2033
US 11007179 ↗ Drug product — Mar 14, 2033
US 11090291 ↗ Drug product — Mar 14, 2033
US 11311516 ↗ Drug product — Mar 14, 2033
US 7741356 ↗ Drug substance — May 27, 2029
US 9675587 ↗ Drug product — Mar 14, 2033
US 11229627 ↗ Drug product — Mar 14, 2033
US 10188632 ↗ Drug product — Mar 14, 2033
US 7741356 ↗ Drug substance — May 27, 2029
US 11229627 ↗ Drug product — Mar 14, 2033
US 11311516 ↗ Drug product — Mar 14, 2033
US 11160792 ↗ Drug product — Mar 14, 2033
US 11160792 ↗ Drug product — Mar 14, 2033
US 10188632 ↗ Drug product — Mar 14, 2033
US 11090291 ↗ Drug product — Mar 14, 2033
Common questions
Is there a generic version of VIBERZI 75 MG TABLET?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for VIBERZI 75 MG TABLET. See the alternatives section for substitutable, lower-cost products.
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.
8 tablets61874-0075-60 2,154 Rx · $3,220,998
8 tablets61874-0075-08 No Medicaid data
16 tablets this page61874-0075-16 No Medicaid data
Drug total (last 4 qtrs): 2,154 Rx · 119,671 units · $3,220,998 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 Viberzi — 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 Viberzi. 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
$14.39M
Claims incl. refills
7.8K
Beneficiaries
4.1K
Spend / beneficiary
$3,519.16
Spend / claim
$1,839.92
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 Viberzi (this brand).

Top reported reactions

Abdominal Pain352
Diarrhoea345
Constipation283
Pancreatitis278
Nausea219
Abdominal Pain Upper210
Inappropriate Schedule Of Drug Administration162

Reporter sex

2,928 reports
Male · 24%
Female · 76%

Serious outcomes

Death66
Disabling38
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 318 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 Per unit Per pack Marketing startStatus
61874-0075-60 60 CARTON in 1 BOTTLE (61874-075-60) / 1 BLISTER PACK in 1 CARTON (61874-075-08) / 8 TABLET, FILM COATED in 1 BLISTER PACK $28.12 / ea $1,687.22 2015-10-01 Active
61874-0075-08 1 BLISTER PACK in 1 CARTON (61874-075-08) / 8 TABLET, FILM COATED in 1 BLISTER PACK — — 2015-10-01 Active
61874-0075-16 You're viewing this 2 BLISTER PACK in 1 CARTON (61874-075-16) / 8 TABLET, FILM COATED in 1 BLISTER PACK (61874-075-08) — — 2026-01-01 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 61874-0075-16?
NDC 61874-0075-16 is listed by the FDA — 2 blister pack in 1 carton / 8 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of Viberzi Eluxadoline 75 mg Tablet, Film Coated?
Bill NDC 61874-0075-16 — the 11-digit billing format is 61874007516. 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 61874-075-16, 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: 61874-0075-16, written without dashes as 61874007516. 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 61874-0075-16, the first segment (61874) is the labeler code FDA assigned to Allergan, Inc.; the middle segment (0075) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (16) 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 Allergan, Inc.. 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 2 other package presentations of this same product, including 8 tablets (61874-0075-60), 8 tablets (61874-0075-08). 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?
Allergan, 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 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage 41 words ▾

1 INDICATIONS AND USAGE VIBERZI is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D). VIBERZI is a mu-opioid receptor agonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D). ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage of VIBERZI is 100 mg taken orally twice daily with food. The recommended dosage of VIBERZI is 75 mg taken orally twice daily with food in patients: unable to tolerate the 100 mg dose of VIBERZI [see Adverse Reactions ( 6.1 ) ]. receiving concomitant OATP1B1 inhibitors [see Drug Interactions ( 7 )] . with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment [see Use in Specific Population s ( 8.6 ) ] . with moderate or severe renal impairment (eGFR less than 60 mL/min/1.73 m 2 ); and in patients with end stage renal disease (ESRD) not yet on dialysis (eGFR less than 15 mL/min/1.73 m 2 ) [see Use in Specific Populations ( 8.7 )].

Discontinue VIBERZI in patients who develop severe constipation [see Warnings and Precautions ( 5.4 )] . Instruct patients if they miss a dose, take the next dose at the regular time and not to take 2 doses at the same time to make up for a missed dose. The recommended dosage in adults is 100 mg twice daily taken with food.

( 2 ) The recommended dosage is 75 mg twice daily taken with food in patients: unable to tolerate the 100 mg dose. ( 2 , 6.1 ) receiving concomitant OATP1B1 inhibitors. ( 2 , 7 ) with mild or moderate hepatic impairment.

( 2 , 8.6 ) with moderate or severe renal impairment; and in patients with end stage renal disease not yet on dialysis. ( 2 , 8.7 ) Discontinue VIBERZI in patients who develop severe constipation. ( 2 ) If a dose is missed, take the next dose at the regular time; do not take 2 doses at once.

( 2 )

💊 Dosage Forms and Strengths 63 words ▾

3 DOSAGE FORMS AND STRENGTHS 75 mg tablets: capsule-shaped tablets are coated in pale-yellow to light tan color debossed with “FX75” on one side. Each tablet contains 75 mg eluxadoline. 100 mg tablets: capsule-shaped tablets are coated in pink-orange to peach color debossed with “FX100” on one side. Each tablet contains 100 mg eluxadoline. Tablets: 75 mg and 100 mg ( 3 )

⛔ Contraindications ~1 min read ▾

4 CONTRAINDICATIONS VIBERZI is contraindicated in patients: Without a gallbladder. These patients are at increased risk of developing serious adverse reactions of pancreatitis and/or sphincter of Oddi spasm [see Warnings and Precautions ( 5.1 , 5.2 )] With known or suspected biliary duct obstruction; or sphincter of Oddi disease or dysfunction. These patients are at increased risk for sphincter of Oddi spasm [see Warnings and Precautions ( 5.1 )].

With alcoholism, alcohol abuse or alcohol addiction, or in patients who drink more than 3 alcoholic beverages per day. These patients are at increased risk for acute pancreatitis [see Warnings and Precautions ( 5.1 )]. With a history of pancreatitis; or structural diseases of the pancreas, including known or suspected pancreatic duct obstruction.

These patients are at increased risk for acute pancreatitis [see Warnings and Precautions ( 5.1 )] . With a known hypersensitivity reaction to VIBERZI [see Warnings and Precautions ( 5.3 )]. With severe hepatic impairment (Child-Pugh Class C).

These patients are at risk for significantly increased plasma concentrations of eluxadoline [see Use in Specific Populations ( 8.6 )] With a history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction. These patients may be at risk for severe complications of bowel obstruction [see Warnings and Precautions ( 5.4 )] . patients without a gallbladder ( 4 ) known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction ( 4 ) alcoholism, alcohol abuse, alcohol addiction, or drink more than 3 alcoholic beverages/day ( 4 ) a history of pancreatitis; structural diseases of the pancreas, including known or suspected pancreatic duct obstruction ( 4 ) patients with a known hypersensitivity reaction to VIBERZI ( 4 , 5.3 ) severe hepatic impairment (Child-Pugh Class C) ( 4 , 8.6 ) a history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Pancreatitis and Sphincter of Oddi Spasm : Monitor patients for new or worsening abdominal pain, with or without nausea and vomiting, or acute biliary pain with liver or pancreatic enzyme elevations; immediately discontinue VIBERZI and seek medical attention if symptoms develop. ( 5.1 , 5.2 ) Hypersensitivity Reactions, including anaphylaxis : Immediately discontinue VIBERZI and seek medical attention if symptoms develop. ( 4 , 5.3 ) Constipation: Instruct patients to stop VIBERZI and immediately contact their healthcare provider if they develop severe constipation.

Avoid use with other drugs that may cause constipation ( 5.4 , 7 )

5.1Pancreatitis Pancreatitis, with or without sphincter of Oddi spasm [ see Warnings and Precautions ( 5.1 ) ] , has been reported in patients taking either the 75 mg or 100 mg dosage of VIBERZI, including serious cases resulting in hospitalization, primarily in patients without a gallbladder. Fatal cases have also been reported in patients without a gallbladder. VIBERZI is contraindicated in patients without a gallbladder [ see Contraindications ( 4 ) ] .

Most of the reported cases of serious pancreatitis occurred within a week of starting treatment with VIBERZI and some developed symptoms after one to two doses. In patients with a gallbladder, evaluate a patient’s alcohol intake prior to starting VIBERZI. Instruct patients to avoid chronic or acute excessive alcohol use while taking VIBERZI.

Monitor for new or worsening abdominal pain that may radiate to the back or shoulder, with or without nausea and vomiting. Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of pancreatitis such as acute abdominal or epigastric pain radiating to the back or shoulder associated with elevations of pancreatic enzymes with or without nausea and vomiting [ see Contraindications ( 4 ) ] .

5.2Sphincter of Oddi Spasm There is a risk of sphincter of Oddi spasm, resulting in pancreatitis or hepatic enzyme elevation associated with acute abdominal pain (e.g., biliary-type pain) in patients taking VIBERZI [ see Adverse Reactions ( 6.1 ) ] . Postmarketing serious adverse reactions of sphincter of Oddi spasm with or without pancreatitis resulting in hospitalization have been reported, primarily in patients without a gallbladder [ see Warnings and Precautions ( 5.1 ) ] . Most of the reported cases of serious sphincter of Oddi spasm occurred within a week of starting treatment with VIBERZI and some developed symptoms after one to two doses.

VIBERZI is contraindicated in patients without a gallbladder [ see Contraindications ( 4 ) ] . Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of sphincter of Oddi spasm such as acute worsening of abdominal pain, (e.g. acute epigastric or biliary [i.e., right upper quadrant] pain), that may radiate to the back or shoulder with or without nausea and vomiting, associated with elevations of pancreatic enzymes or liver transaminases. Do not restart VIBERZI in patients who developed biliary duct obstruction or sphincter of Oddi spasm while taking VIBERZI [ see Contraindications ( 4 ) ] .

5.3Hypersensitivity Reactions In postmarketing experience, serious hypersensitivity reactions (including anaphylaxis) have been reported following VIBERZI administration. Some of these reactions occurred after the first one or two doses of VIBERZI [ see Adverse Reactions ( 6.2 )] . Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of a hypersensitivity reaction [ see Contraindications ( 4 ) ] .

5.4Constipation Constipation, sometimes requiring hospitalization, has been reported following VIBERZI administration. In postmarketing experience, severe cases with development of intestinal obstruction, intestinal perforation, and fecal impaction, requiring intervention, have also been reported. Instruct…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions described below and elsewhere in the labeling include: Pancreatitis [see Warnings and Precautions ( 5.1 )] Sphincter of Oddi Spasm [ see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] Constipation [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (>5%) are constipation, nausea and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1- 800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial s Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates 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. Over 1700 patients with IBS-D have been treated with 75 or 100 mg of VIBERZI twice daily in controlled trials. Exposures from placebo-controlled clinical trials in adult patients with IBS-D included 1391 exposed for 3 months, 1001 exposed for 6 months and 488 exposed for one year.

Demographic characteristics were comparable between the treatment groups [see Clinical Studies ( 14 )] . Data described below represent pooled data compared to placebo across the randomized trials. Pancreatitis Cases of pancreatitis, not associated with sphincter of Oddi spasm, were reported in 2/807 (0.2%) of patients receiving 75 mg and 3/1032 (0.3%) of patients receiving 100 mg VIBERZI twice daily in clinical trials.

Of these 5 cases, 3 were associated with excessive alcohol intake, one was associated with biliary sludge, and in one case the patient discontinued VIBERZI 2 weeks prior to the onset of symptoms. All pancreatic events resolved with lipase normalization upon discontinuation of VIBERZI, with 80% (4/5) resolving within 1 week of treatment discontinuation. The case of sphincter of Oddi spasm-induced pancreatitis resolved within 24 hours of discontinuation.

Sp h incter of Oddi Spasm In clinical trials, sphincter of Oddi spasm occurred in 0.2% (2/807) of patients receiving 75 mg and 0.8% (8/1032) of patients receiving 100 mg VIBERZI twice daily. Among patients receiving 75 mg, 1/807 (0.1%) patient experienced a sphincter of Oddi spasm presenting with abdominal pain but with lipase elevation less than 3 times the upper limit of normal (ULN) and 1/ 807 (0.1%) patient experienced a sphincter of Oddi spasm manifested as elevated hepatic enzymes associated with abdominal pain Among patients receiving 100 mg, 1/1032 (0.1%) patient experienced a sphincter of Oddi spasm manifested as pancreatitis and 7/1032 (0.7%) patients experienced sphincter of Oddi spasm manifested as elevated hepatic enzymes associated with abdominal pain Of those patients who experienced a sphincter of Oddi spasm, 80% (8/10) reported their first onset of symptoms within the first week of treatment.

The case of sphincter of Oddi spasm-induced pancreatitis occurred within minutes of taking the first dose of VIBERZI. No cases of sphincter of Oddi spasm occurred greater than 1 month after treatment onset. All events resolved upon discontinuation of VIBERZI, with symptoms typically improved by the following day.

Common Adverse Reactions Table 1 provides the incidence of common adverse reactions reported in > 2% of IBS-D patients in either VIBERZI treatment group and at an incidence greater than in the placebo group. Table 1: Common* Adverse Reactions in the Placebo-Controlled Studies in IBS-D Patients Adverse Reactions VIBERZI 100 mg twice daily (N= 1032) % VIBERZI 75 mg twice daily (N=807) % Placebo (N=975) % Constipation 8 7 2 Nausea 7 8 5 Abdominal Pain** 7 6 4 Upper Respiratory Tract Infection 5 3 4 Vomiting 4 4 1 Nasopharyngitis 3 4 3 Abdominal Distention 3 3 2 Bronchitis 3 3 2 Dizziness 3 3 2 Flatulence 3 3 2 Rash*** 3 3 2 Increased ALT 3 2 1 Fatigue 2 3 2 Viral gastroenteritis 1 3 2 * Reported in > 2% of VIBERZI-treated patients at either dose and at…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Tables 2 and 3 include drugs which demonstrated a clinically important drug interaction with VIBERZI or which potentially may result in clinically relevant interactions. Table 2: Established and Other Potentially Clinically Relevant Interactions Affecting VIBERZI OATP1B1 Inhibitors Clinical Impact: Increased exposure to eluxadoline when coadministered with cyclosporine [ see Clinical Pharmacology ( 12.3 ) ] Intervention: Administer VIBERZI at a dose of 75 mg twice daily [see Dosage and Administration ( 2 )] and monitor patients for impaired mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery and for other eluxadoline-related adverse reactions [see Adverse Reactions ( 6.1 )] .

Examples: cyclosporine, gemfibrozil, antiretrovirals (atazanavir, lopinavir, ritonavir, saquinavir, tipranavir), rifampin, eltrombopag Drugs that Cause Constipation Clinical Impact: Increased risk for constipation related adverse reactions and potential for constipation related serious adverse reactions Intervention: Avoid use with other drugs that may cause constipation (see below); loperamide may be used occasionally for acute management of severe diarrhea but avoid chronic use. Discontinue loperamide immediately if constipation occurs.

Examples: alosetron, anticholinergics, opioids Table 3: Established and Other Potentially Clinically Relevant Interactions Affecting Drugs Co-Administered with VIBERZI OATP1B1 and BCRP Substrate Clinical Impact: VIBERZI may increase the exposure of co-administered OATP1B1 and BCRP substrates. Increased exposure to rosuvastatin when co-administered with VIBERZI with a potential for increased risk of myopathy/rhabdomyolysis [ see Clinical Pharmacology ( 12.3 ) ] Intervention: Use the lowest effective dose of rosuvastatin (see prescribing information of rosuvastatin for additional information on recommended dosing).

See full prescribing information for clinically relevant interactions. ( 7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no studies with VIBERZI in pregnant women that inform any drug-associated risks. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.

In animal reproduction studies, oral and subcutaneous administration of eluxadoline to rats and rabbits during organogenesis at doses approximately 51 and 115 times the human exposure after a single oral dose of 100 mg, respectively, demonstrated no teratogenic effects. In a pre- and postnatal development study in rats, no adverse effects were observed in offspring with oral administration of eluxadoline at doses approximately 10 times the human exposure ( see Data ) . Data Animal Data Eluxadoline administered as combined oral (1000 mg/kg/day) and subcutaneous (5 mg/kg/day) doses during the period of organogenesis to rats and rabbits (exposures about 51 and 115 times, respectively, the human AUC of 24 ng.h/mL after a single oral dose of 100 mg) did not cause any adverse effects on embryofetal development.

A pre- and postnatal development study in rats showed no evidence of any adverse effect on pre- and postnatal development at oral doses of eluxadoline up to 1000 mg/kg/day (with exposures about 10 times the human AUC of 24 ng.h/mL after a single oral dose of 100 mg). In the same study, eluxadoline was detected in the milk of lactating rats administered oral doses of 100, 300 and 1000 mg/kg/day (with exposures about 1.8, 3 and 10 times, respectively, the human AUC of 24 ng.h/mL after a single oral dose of 100 mg). Milk samples were collected from six lactating females per group on lactation day 12.

Mean concentrations of eluxadoline in the milk of lactating rats on lactation day 12 were 2.78, 5.49 and 44.02 ng/mL at 100, 300 and 1000 mg/kg/day, respectively.

8.2Lactation Risk Summary No data are available regarding the presence of eluxadoline in human milk, the effects of eluxadoline on the breastfed infant, or the effects of eluxadoline on milk production. However, eluxadoline is present in rat milk [see Use in Specific Populations ( 8.1 ) ] . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VIBERZI and any potential adverse effects on the breastfed infant from VIBERZI or from the underlying maternal condition.

8. 4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. Juvenile Toxicology Data Eluxadoline was orally administered to juvenile rats at 500, 750, and 1500 mg/kg/day (about 16, 54 and 30 times, respectively, the human AUC of 24 ng.h/mL after a single oral dose of 100 mg) for 4 weeks.

There were no adverse physiologic effects related to eluxadoline. Based on these results, the NOAEL for male and female juvenile rats was 1500 mg/kg/day (about 30 times the human AUC of 24 ng.h/mL after a single oral dose of 100 mg). 8.

5 Geriatric Use Of 1795 IBS-D patients in clinical trials of VIBERZI who received 75 mg or 100 mg twice daily, 139 (7.7%) were at least 65 years of age, while 15 (0.8%) were at least 75 years old. No overall differences in effectiveness were observed between these patients and younger patients. There were no overall differences in the types of adverse reactions observed between elderly and younger patients; however, a higher proportion of elderly patients than younger patients experienced adverse reactions (66% vs 59%), serious adverse reactions (9% vs 4%), and gastrointestinal adverse reactions (39% vs 28%).

8. 6 Hepatic Impairment Plasma concentrations of eluxadoline increase in patients with hepatic impairment [see Clinical Pharmacology ( 12.3 )] . VIBERZI is contraindicated in patients with severe hepatic impairment (Child-Pugh Class C) as plasma concentrations of eluxadoline increase significa…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no studies with VIBERZI in pregnant women that inform any drug-associated risks. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.

In animal reproduction studies, oral and subcutaneous administration of eluxadoline to rats and rabbits during organogenesis at doses approximately 51 and 115 times the human exposure after a single oral dose of 100 mg, respectively, demonstrated no teratogenic effects. In a pre- and postnatal development study in rats, no adverse effects were observed in offspring with oral administration of eluxadoline at doses approximately 10 times the human exposure ( see Data ) . Data Animal Data Eluxadoline administered as combined oral (1000 mg/kg/day) and subcutaneous (5 mg/kg/day) doses during the period of organogenesis to rats and rabbits (exposures about 51 and 115 times, respectively, the human AUC of 24 ng.h/mL after a single oral dose of 100 mg) did not cause any adverse effects on embryofetal development.

A pre- and postnatal development study in rats showed no evidence of any adverse effect on pre- and postnatal development at oral doses of eluxadoline up to 1000 mg/kg/day (with exposures about 10 times the human AUC of 24 ng.h/mL after a single oral dose of 100 mg). In the same study, eluxadoline was detected in the milk of lactating rats administered oral doses of 100, 300 and 1000 mg/kg/day (with exposures about 1.8, 3 and 10 times, respectively, the human AUC of 24 ng.h/mL after a single oral dose of 100 mg). Milk samples were collected from six lactating females per group on lactation day 12.

Mean concentrations of eluxadoline in the milk of lactating rats on lactation day 12 were 2.78, 5.49 and 44.02 ng/mL at 100, 300 and 1000 mg/kg/day, respectively.

🧒 Pediatric Use 95 words ▾

8. 4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. Juvenile Toxicology Data Eluxadoline was orally administered to juvenile rats at 500, 750, and 1500 mg/kg/day (about 16, 54 and 30 times, respectively, the human AUC of 24 ng.h/mL after a single oral dose of 100 mg) for 4 weeks.

There were no adverse physiologic effects related to eluxadoline. Based on these results, the NOAEL for male and female juvenile rats was 1500 mg/kg/day (about 30 times the human AUC of 24 ng.h/mL after a single oral dose of 100 mg).

🧓 Geriatric Use 99 words ▾

8. 5 Geriatric Use Of 1795 IBS-D patients in clinical trials of VIBERZI who received 75 mg or 100 mg twice daily, 139 (7.7%) were at least 65 years of age, while 15 (0.8%) were at least 75 years old. No overall differences in effectiveness were observed between these patients and younger patients.

There were no overall differences in the types of adverse reactions observed between elderly and younger patients; however, a higher proportion of elderly patients than younger patients experienced adverse reactions (66% vs 59%), serious adverse reactions (9% vs 4%), and gastrointestinal adverse reactions (39% vs 28%).

🆘 Overdosage 93 words ▾

10 OVERDOSAGE No reports of overdosage with VIBERZI have been reported. In the event of acute overdose, the stomach should be emptied and adequate hydration maintained. The patient should be carefully observed and given standard supportive treatment as required.

Given eluxadoline’s action at opioid receptors, administration of a narcotic mu-opioid antagonist, such as naloxone, should be considered. Considering the short half-life of naloxone, repeated administration may be necessary. In the event of naloxone administration, subjects should be monitored closely for the return of overdose symptoms, which may indicate need for repeated naloxone injection.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Eluxadoline is a mu-opioid receptor agonist; eluxadoline is also a delta opioid receptor antagonist and a kappa opioid receptor agonist. The binding affinities (Ki) of eluxadoline for the human mu and delta opioid receptors are 1.8 nM and 430 nM, respectively. The binding affinity (Ki) of eluxadoline for the human kappa opioid receptor has not been determined; however, the Ki for guinea pig cerebellum kappa opioid receptor is 55 nM.

In animals, eluxadoline interacts with opioid receptors in the gut.

12.2Pharmacodynamics Cardiac Electrophysiology At a dose 10 times the maximum recommended dose (100 mg), VIBERZI does not prolong the QT interval to any clinically relevant extent.

12.3Pharmacokinetics Following oral administration of 100 mg VIBERZI in healthy subjects, the C max of eluxadoline was approximately 2 to 4 ng/mL and AUC was 12 to 22 ng.h/mL. Eluxadoline has approximately linear pharmacokinetics with no accumulation upon repeated twice daily dosing. The variability of eluxadoline pharmacokinetic parameters ranges from 51% to 98%.

Absorption Absolute bioavailability of eluxadoline has not been determined. Effect of Food The median T max value was 1.5 hours (range: 1 to 8 hours) under fed conditions and 2 hours (range: 0.5 to 6 hours) under fasting conditions [see Dosage and Administration ( 2 )] . The administration of VIBERZI with a high fat meal that contained approximately 800 to 1000 total calories, with 50% of calories being derived from fat content decreased the C max of eluxadoline by 50% and AUC by 60%.

Distribution Plasma protein binding of eluxadoline was 81%. Elimination The mean plasma elimination half-life of eluxadoline ranged from 3.7 hours to 6 hours. Metabolism Cytochrome P450 (CYP) and UGT pathways have minimal involvement in the metabolism of eluxadoline.

It is unlikely that metabolism of eluxadoline by these enzymes has a clinically meaningful impact on systemic exposure. Excretion Following a single oral dose of 300 mg [ 14 C] eluxadoline in healthy male subjects, 82.2% of the total radioactivity was recovered in feces within 336 hours and less than 1% was recovered in urine within 192 hours. Speci fic Populations Patients with Hepatic Impairment Following a single oral 100–mg dose in subjects with varying degrees of liver impairment and healthy subjects, mean eluxadoline plasma exposure was 6-fold, 4-fold, and 16-fold higher in mild, moderate, and severe hepatically impaired subjects (Child Pugh Class A, B, C), respectively, compared to the subjects with normal liver function [see Dosage and Administration ( 2 ) , Contraindications ( 4 ), Use in Specific Population s ( 8.6 ) ] .

P a ti e nts with R e n a l I mp a i r m e nt Following a single oral 100 mg dose, the mean eluxadoline C max and AUC 0-t were 3.7-fold and 4.7-fold higher, respectively, in subjects with severe renal impairment (eGFR 15 to 30 mL/min/1.73 m 2 , n=2) and 2.4-fold and 5.9-fold higher, respectively, in subjects with ESRD not yet on dialysis (eGFR less than 15 mL/min/1.73 m 2 , n=6) compared to healthy subjects with normal renal function (n=6) [see Dosage and Administration ( 2 ), Use in Specific Populations ( 8.7 )]. Drug Interaction Studies In Vitro Assessment of Drug Interactions In vitro studies indicate that eluxadoline is neither an inducer of CYP1A2, CYP2C9, CYP2C19, and CYP3A4, nor an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, and CYP2D6 at clinically relevant systemic concentrations.

Although CYP2E1 was slightly inhibited by eluxadoline (IC 50 of approximately 20 micromolar [11 mcg/mL]), clinically meaningful interactions are unlikely. Despite mechanism-based inhibition of CYP3A4 in vitro , eluxadoline did not have a clinically meaningful drug-drug interaction with the CYP3A4 substrate midazolam. I n vitro studies suggest that eluxadoline is a substrate for OAT3, OATP1B1, BSEP and MRP2, but not for OCT1, OCT2, OAT1, OATP1B3, P-gp and BCRP.

Based on the in vi…

🧬 Mechanism of Action 84 words ▾

12.1Mechanism of Action Eluxadoline is a mu-opioid receptor agonist; eluxadoline is also a delta opioid receptor antagonist and a kappa opioid receptor agonist. The binding affinities (Ki) of eluxadoline for the human mu and delta opioid receptors are 1.8 nM and 430 nM, respectively. The binding affinity (Ki) of eluxadoline for the human kappa opioid receptor has not been determined; however, the Ki for guinea pig cerebellum kappa opioid receptor is 55 nM.

In animals, eluxadoline interacts with opioid receptors in the gut.

📦 How Supplied / Storage and Handling 80 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING VIBERZI is available as: 75 mg tablets: capsule-shaped tablets, coated in pale-yellow to light tan color, debossed with “FX75” on one side. Bottle of 60: NDC 61874-075-60 100 mg tablets: capsule-shaped tablets, coated in pink-orange to peach color, debossed with “FX100” on one side. Bottle of 60: NDC 61874-100-60 Store VIBERZI tablets at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] .

📋 Description 121 words ▾

11 DESCRIPTION The active ingredient in VIBERZI is eluxadoline, a mu-opioid receptor agonist. The full chemical name is 5-[[[(2S)-2-amino-3-[4-(aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid. Eluxadoline has a molecular weight of 569.65 and a molecular formula of C 32 H 35 N 5 O 5 .

The chemical structure of eluxadoline is: VIBERZI is available as 75 mg and 100 mg tablets for oral administration. In addition to the active ingredient, eluxadoline, each tablet contains the following inactive ingredients: silicified microcrystalline cellulose, colloidal silica, crospovidone, mannitol, magnesium stearate, and Opadry II (partially hydrolyzed polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red). The chemical structure of eluxadoline is Eluxadoline has a molecular weight of 569.65 and a molecular formula of C32H35N5O5.

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Instruct patients to: stop VIBERZI immediately and seek medical attention if unusual or severe abdominal pain that may radiate to the back or shoulder with or without nausea and vomiting, develops [see Warnings and Precautions ( 5.1 , 5.2 )] . avoid chronic or acute excessive alcohol use while taking VIBERZI [see Warnings and Precautions ( 5.1 )] . stop VIBERZI immediately and seek medical attention if symptoms of a hypersensitivity reaction develop [see Warnings and Precautions ( 5.3 )]. stop VIBERZI and immediately call their health care provider if they experience severe constipation [ see Dosage and Administration ( 2 ), Warnings and Precautions ( 5.4 ) ] . take one tablet twice daily with food . if they miss a dose, take the next dose at the regular time.

Do not take 2 doses at the same time to make up for a missed dose. call their healthcare provider if they are unable to tolerate VIBERZI not take alosetron with VIBERZI or not take loperamide on a ch r onic basis with VIBERZI due to the potential for constipation. Loperamide may occasionally be used with VIBERZI for acute management of severe diarrhea, but must be discontinued if constipation develops. Also, instruct patients to avoid taking VIBERZI with other medications that may cause constipation (for example opioids, anticholinergics, etc.) [see Drug Interactions ( 7 )] .

Distributed by: AbbVie, Inc. North Chicago, IL 60064 VIBERZI and its design are trademarks of Allergan Holdings Unlimited Company, an AbbVie company. © 2024 AbbVie. All rights reserved.

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE VIBERZI (vye BER zee), CIV (eluxadoline ) tablets What is the most important information I should know about VIBERZI? VIBERZI can cause serious side effects, including: Inflammation of the pancreas (pancreatitis). Pancreatitis has happened most often in people who do not have a gallbladder and can lead to hospitalization.

Pancreatitis has led to death in some people who do not have a gallbladder. Pancreatitis usually happens within the first week of treatment with VIBERZI but can happen after 1 to 2 doses of VIBERZI. Your risk of getting pancreatitis is increased if you drink more than 3 alcoholic drinks a day.

Limit your use of alcoholic drinks while you are taking VIBERZI. Sphincter of Oddi spasm. The sphincter of Oddi is a muscular valve that controls the flow of digestive juices (bile and pancreatic juice) to the first part of your small intestine.

A sphincter of Oddi spasm can cause an increase in your liver and pancreas enzymes and inflammation of the pancreas (pancreatitis) that can cause sudden stomach-area (abdomen) pain. Sphincter of Oddi spasm has happened most often in people who do not have a gallbladder and can lead to hospitalization. This spasm usually happens within the first week of treatment with VIBERZI but can happen after 1 or 2 doses of VIBERZI.

Stop taking VIBERZI right away and get emergency medical care if you have new or worsening stomach-area (abdomen) pain or pain in the upper right side of your stomach-area (abdomen) that may move to your back or shoulder, with or without nausea and vomiting. Serious allergic reactions. Serious allergic reactions have happened in some people after taking 1 or 2 doses of VIBERZI.

Stop taking VIBERZI right away and get emergency medical care if you have signs or symptoms of an allergic reaction, including: ○ swelling of your face, lips, mouth or tongue ○ itching ○ shortness of breath or other breathing problems ○ rash ○ hives Constipation . Constipation, including severe constipation that can lead to hospitalization has happened after taking VIBERZI. Stop taking VIBERZI and call your doctor right away if you develop severe constipation while taking VIBERZI.

What is VIBERZI? VIBERZI is a prescription medicine used to treat adults who have irritable bowel syndrome with diarrhea (IBS-D). VIBERZI is a controlled substance (CIV) because it contains eluxadoline and may be abused or lead to drug dependence.

Keep your VIBERZI in a safe place, to protect it from theft. Never give your VIBERZI to anyone else, because it may harm them. Selling or giving away this medicine is against the law.

It is not known if VIBERZI is safe and effective in children. People 65 years old and older have had an increased number of side effects, including serious side effects and stomach problems, while taking VIBERZI than people younger than 65 years old have had. Do not take VIBERZI if you: do not have a gallbladder. have or may have had a blockage in your gallbladder or a sphincter of Oddi problem. have or had problems with alcohol abuse, alcohol addiction, or drink more than 3 alcoholic drinks a day. have had inflammation of your pancreas (pancreatitis) or other pancreas problems, including if you have had or may have had a blockage in your pancreas. have had an allergic reaction to VIBERZI. have severe liver problems. have had long-lasting (chronic) or severe constipation, or problems caused by constipation. have or may have had a bowel blockage (intestinal obstruction).

Talk to your doctor if you are not sure if you have any of these conditions. Before taking VIBERZI, tell your doctor about all of your medical conditions, including if you: See “ What is the most important information I should know about VIBERZI? ” have liver problems. are pregnant or plan to become pregnant. It is not known if VIBERZI will harm your unborn baby. are breastfeeding or plan to breastfeed.

It is not known if VIBERZI passes into your breast milk or could harm your baby. Tell your doctor about a…

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.