viberzi

Generic: eluxadoline

Labeler: allergan, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name viberzi
Generic Name eluxadoline
Labeler allergan, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

eluxadoline 100 mg/1

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 61874-100
Product ID 61874-100_b293ef5c-6507-4578-a0e8-aa7356b3d50f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA206940
DEA Schedule civ
Listing Expiration 2027-12-31
Marketing Start 2015-10-01

Pharmacologic Class

Established (EPC)
mu-opioid receptor agonist [epc]
Mechanism of Action
opioid mu-receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61874100
Hyphenated Format 61874-100

Supplemental Identifiers

RxCUI
1653786 1653792 1719764 1719766
UPC
0361874075601
UNII
45TPJ4MBQ1
NUI
N0000191867 N0000191866

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name viberzi (source: ndc)
Generic Name eluxadoline (source: ndc)
Application Number NDA206940 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (61874-100-08) / 8 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (61874-100-16) / 16 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (61874-100-60) / 60 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (3)

61874-100-08 1 BLISTER PACK in 1 CARTON (61874-100-08) / 8 TABLET, FILM COATED in 1 BLISTER PACK 61874-100-16 1 BLISTER PACK in 1 CARTON (61874-100-16) / 16 TABLET, FILM COATED in 1 BLISTER PACK 61874-100-60 1 BOTTLE in 1 CARTON (61874-100-60) / 60 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

eluxadoline (100 mg/1)

Linked Drug Pages (1)

Viberzi ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b293ef5c-6507-4578-a0e8-aa7356b3d50f", "openfda": {"nui": ["N0000191867", "N0000191866"], "upc": ["0361874075601"], "unii": ["45TPJ4MBQ1"], "rxcui": ["1653786", "1653792", "1719764", "1719766"], "spl_set_id": ["7821bd40-4c84-4984-951b-6436ae20421a"], "pharm_class_epc": ["mu-Opioid Receptor Agonist [EPC]"], "pharm_class_moa": ["Opioid mu-Receptor Agonists [MoA]"], "manufacturer_name": ["Allergan, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BLISTER PACK in 1 CARTON (61874-100-08)  / 8 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "61874-100-08", "marketing_start_date": "20151001"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (61874-100-16)  / 16 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "61874-100-16", "marketing_start_date": "20250901"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (61874-100-60)  / 60 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "61874-100-60", "marketing_start_date": "20151001"}], "brand_name": "Viberzi", "product_id": "61874-100_b293ef5c-6507-4578-a0e8-aa7356b3d50f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid mu-Receptor Agonists [MoA]", "mu-Opioid Receptor Agonist [EPC]"], "product_ndc": "61874-100", "dea_schedule": "CIV", "generic_name": "Eluxadoline", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Viberzi", "active_ingredients": [{"name": "ELUXADOLINE", "strength": "100 mg/1"}], "application_number": "NDA206940", "marketing_category": "NDA", "marketing_start_date": "20151001", "listing_expiration_date": "20271231"}