prucalopride

Generic: prucalopride

Labeler: viona pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prucalopride
Generic Name prucalopride
Labeler viona pharmaceuticals inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

prucalopride succinate 2 mg/1

Manufacturer
Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-222
Product ID 72578-222_6d8aeb40-9dce-4be0-897e-87ad2c5d828e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218056
Listing Expiration 2027-12-31
Marketing Start 2026-02-02

Pharmacologic Class

Classes
serotonin 4 receptor agonists [moa] serotonin-4 receptor agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72578222
Hyphenated Format 72578-222

Supplemental Identifiers

RxCUI
2107345 2107353
UNII
4V2G75E1CK

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 prucalopride (source: ndc)
Generic Name prucalopride (source: ndc)
Application Number ANDA218056 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (72578-222-06)
source: ndc

Packages (1)

72578-222-06 30 TABLET, FILM COATED in 1 BOTTLE (72578-222-06)

Ingredients (1)

prucalopride succinate (2 mg/1)

Linked Drug Pages (1)

prucalopride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6d8aeb40-9dce-4be0-897e-87ad2c5d828e", "openfda": {"unii": ["4V2G75E1CK"], "rxcui": ["2107345", "2107353"], "spl_set_id": ["af559917-802b-486c-9f7b-b770115acac8"], "manufacturer_name": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72578-222-06)", "package_ndc": "72578-222-06", "marketing_start_date": "20260202"}], "brand_name": "prucalopride", "product_id": "72578-222_6d8aeb40-9dce-4be0-897e-87ad2c5d828e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 4 Receptor Agonists [MoA]", "Serotonin-4 Receptor Agonist [EPC]"], "product_ndc": "72578-222", "generic_name": "prucalopride", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "prucalopride", "active_ingredients": [{"name": "PRUCALOPRIDE SUCCINATE", "strength": "2 mg/1"}], "application_number": "ANDA218056", "marketing_category": "ANDA", "marketing_start_date": "20260202", "listing_expiration_date": "20271231"}