Viberzi
These highlights do not include all the information needed to use VIBERZI safely and effectively. See full prescribing information for VIBERZI . VIBERZI (eluxadoline) tablets, for oral use , C IV Initial U.S. Approval: 2015
Approved
Approval ID
7821bd40-4c84-4984-951b-6436ae20421a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2020
Manufacturers
FDA
Allergan, Inc.
DUNS: 144796497
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Eluxadoline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61874-075
Application NumberNDA206940
Product Classification
M
Marketing Category
C73594
G
Generic Name
Eluxadoline
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2023
FDA Product Classification
INGREDIENTS (12)
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
ELUXADOLINEActive
Quantity: 75 mg in 1 1
Code: 45TPJ4MBQ1
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
Eluxadoline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61874-100
Application NumberNDA206940
Product Classification
M
Marketing Category
C73594
G
Generic Name
Eluxadoline
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2023
FDA Product Classification
INGREDIENTS (12)
ELUXADOLINEActive
Quantity: 100 mg in 1 1
Code: 45TPJ4MBQ1
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT