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Prescription medicine

Eluxadoline

Drug class: mu-Opioid Receptor Agonist

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Eluxadoline used for?
The FDA-approved label (Viberzi, Allergan, Inc., July 16, 2024) says: “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).” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Eluxadoline have a boxed warning?
No. None of the 1 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Eluxadoline?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Eluxadoline been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Eluxadoline?
1 company lists prescription products of Eluxadoline in the FDA NDC Directory, including Allergan, Inc..

What Eluxadoline is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

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).

— FDA label: Viberzi, Allergan, Inc., effective July 16, 2024. Read the full label on DailyMed →

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Related medical specialties

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

Forms and how it is given

Dosage formsTablet, film coated
RouteOral
Prescription products2 in the FDA NDC Directory
Brand namesViberzi

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Eluxadoline, by strength and form
Strength and formGeneric or brandPharmacies pay
eluxadoline 100 mg
tablet, film coated
Brand: Viberzi $28.09 per tablet
eluxadoline 75 mg
tablet, film coated
Brand: Viberzi $28.11 per tablet

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA206940
VIBERZI
AbbvieMay 27, 2015 6, latest June 17, 2020
2020: Labeling · 2018: Labeling · 2018: Labeling

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)1653786, 1653792, 1719764, 1719766
SPL set ID of the quoted label7821bd40-4c84-4984-951b-6436ae20421a
FDA labels (SPL)1
FDA applicationsNDA206940
Active ingredients (FDA)ELUXADOLINE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Viberzi, Allergan, Inc., effective July 16, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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