NDC 61874-100

Viberzi

Eluxadoline

Viberzi is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Eluxadoline.

Product ID61874-100_0ad2e4fc-955d-41f7-a2ae-45e92b6bcefd
NDC61874-100
Product TypeHuman Prescription Drug
Proprietary NameViberzi
Generic NameEluxadoline
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-10-01
Marketing CategoryNDA / NDA
Application NumberNDA206940
Labeler NameAllergan, Inc.
Substance NameELUXADOLINE
Active Ingredient Strength100 mg/1
Pharm ClassesOpioid mu-Receptor Agonists [MoA], mu-Opioid Receptor Agonist [EPC]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 61874-100-60

60 CARTON in 1 BOTTLE (61874-100-60) > 1 BLISTER PACK in 1 CARTON (61874-100-08) > 8 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2015-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61874-100-08 [61874010008]

Viberzi TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA206940
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-10-01

NDC 61874-100-60 [61874010060]

Viberzi TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA206940
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-10-01

Drug Details

Active Ingredients

IngredientStrength
ELUXADOLINE100 mg/1

OpenFDA Data

SPL SET ID:7821bd40-4c84-4984-951b-6436ae20421a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1719764
  • 1653786
  • 1719766
  • 1653792
  • Pharmacological Class

    • mu-Opioid Receptor Agonist [EPC]
    • Opioid mu-Receptor Agonists [MoA]

    Medicade Reported Pricing

    61874010060 VIBERZI 100 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Viberzi" or generic name "Eluxadoline"

    NDCBrand NameGeneric Name
    61874-075ViberziEluxadoline
    61874-100ViberziEluxadoline

    Trademark Results [Viberzi]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VIBERZI
    VIBERZI
    86803941 4982924 Live/Registered
    ALLERGAN HOLDINGS UNLIMITED COMPANY
    2015-10-29
    VIBERZI
    VIBERZI
    86481014 4928665 Live/Registered
    ALLERGAN HOLDINGS UNLIMITED COMPANY
    2014-12-15

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