FDA.reportPublic FDA data

Viberzi

Product NDC
61874-100
11-digit product format
618740100
Labeler code
61874
Product ID
61874-100_772a8af8-21e9-46bb-af21-34365ae0c477
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eluxadoline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Allergan, Inc.
Application
NDA206940
Marketing category
NDA
Marketing start
2015-10-01
Substance
ELUXADOLINE
Active strength
100 mg/1
Pharmacologic classes
Opioid mu-Receptor Agonists [MoA], mu-Opioid Receptor Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Viberzi
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ELUXADOLINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii45TPJ4MBQ1
Rxcui1653786, 1653792, 1719764, 1719766

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7703b660-37de-4791-993b-e4219688df8eProduct name120150611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61874-100-08Viberzi8 in 1 BLISTER PACKTABLET, FILM COATED827
61874-100-08Viberzi1 in 1 CARTONTABLET, FILM COATED127
61874-100-16Viberzi16 in 1 BLISTER PACKTABLET, FILM COATED1627
61874-100-16Viberzi1 in 1 CARTONTABLET, FILM COATED127
61874-100-60Viberzi60 in 1 BOTTLETABLET, FILM COATED6027
61874-100-60Viberzi1 in 1 CARTONTABLET, FILM COATED127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61874-100-60EA - Each61874-100c3b4df5b-29ce-4112-b03b-6b01c508087a12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EluxadolineACTIVE INGREDIENT45TPJ4MBQ1VIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC]3
EluxadolineACTIVE MOIETY45TPJ4MBQ1VIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC]3
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UVIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC]3
CrospovidoneINACTIVE INGREDIENT68401960MKVIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC]3
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675VIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC]3
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTVIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC]3
Magnesium StearateINACTIVE INGREDIENT70097M6I30VIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC]3
MannitolINACTIVE INGREDIENT3OWL53L36AVIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC]3
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1AVIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC]3
Polyvinyl AlcoholINACTIVE INGREDIENT532B59J990VIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC]3
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4VIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC]3
TalcINACTIVE INGREDIENT7SEV7J4R1UVIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC]3
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPVIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61874-100VIBERZI (ELUXADOLINE) TABLET, FILM COATED [ALLERGAN, INC.]23Current NDC, Legacy NDC, 6 package rows20250116_7821bd40-4c84-4984-951b-6436ae20421a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719764eluxadoline 100 MG Oral TabletPSN7821bd40-4c84-4984-951b-6436ae20421a27
1653786eluxadoline 75 MG Oral TabletPSN7821bd40-4c84-4984-951b-6436ae20421a27
1719766Viberzi 100 MG Oral TabletPSN7821bd40-4c84-4984-951b-6436ae20421a27
1653792Viberzi 75 MG Oral TabletPSN7821bd40-4c84-4984-951b-6436ae20421a27
1719766eluxadoline 100 MG Oral Tablet [Viberzi]SBD7821bd40-4c84-4984-951b-6436ae20421a27
1653792eluxadoline 75 MG Oral Tablet [Viberzi]SBD7821bd40-4c84-4984-951b-6436ae20421a27
1719764eluxadoline 100 MG Oral TabletSCD7821bd40-4c84-4984-951b-6436ae20421a27
1653786eluxadoline 75 MG Oral TabletSCD7821bd40-4c84-4984-951b-6436ae20421a27
1719766Viberzi 100 MG Oral TabletSY7821bd40-4c84-4984-951b-6436ae20421a27
1653792Viberzi 75 MG Oral TabletSY7821bd40-4c84-4984-951b-6436ae20421a27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61874-100-08618740100081 BLISTER PACK in 1 CARTON (61874-100-08) / 8 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2015-10-01YesNoHistorical
61874-100-16618740100161 BLISTER PACK in 1 CARTON (61874-100-16) / 16 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2025-09-01YesNoHistorical
61874-100-60618740100601 BOTTLE in 1 CARTON (61874-100-60) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-10-010000-00-00NoNoCurrent