prucalopride

Generic: prucalopride

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prucalopride
Generic Name prucalopride
Labeler apotex corp.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

prucalopride succinate 2 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-4807
Product ID 60505-4807_06f30acf-a55e-9a8d-e4e2-46d3a7d66639
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218977
Listing Expiration 2026-12-31
Marketing Start 2025-06-24

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 605054807
Hyphenated Format 60505-4807

Supplemental Identifiers

RxCUI
2107345 2107353
UPC
0360505480630 0360505480739
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 ANDA218977 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (60505-4807-3)
source: ndc

Packages (1)

60505-4807-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-4807-3)

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": "06f30acf-a55e-9a8d-e4e2-46d3a7d66639", "openfda": {"upc": ["0360505480630", "0360505480739"], "unii": ["4V2G75E1CK"], "rxcui": ["2107345", "2107353"], "spl_set_id": ["01dcea95-b391-79da-bbfe-412f39022e9a"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (60505-4807-3)", "package_ndc": "60505-4807-3", "marketing_start_date": "20250624"}], "brand_name": "Prucalopride", "product_id": "60505-4807_06f30acf-a55e-9a8d-e4e2-46d3a7d66639", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 4 Receptor Agonists [MoA]", "Serotonin-4 Receptor Agonist [EPC]"], "product_ndc": "60505-4807", "generic_name": "Prucalopride", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prucalopride", "active_ingredients": [{"name": "PRUCALOPRIDE SUCCINATE", "strength": "2 mg/1"}], "application_number": "ANDA218977", "marketing_category": "ANDA", "marketing_start_date": "20250624", "listing_expiration_date": "20261231"}