prucalopride

Generic: prucalopride

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

prucalopride succinate 1 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-218
Product ID 72205-218_89a7fce6-5d3e-4a71-a86c-06d209951c63
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218177
Listing Expiration 2027-12-31
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 72205218
Hyphenated Format 72205-218

Supplemental Identifiers

RxCUI
2107345 2107353
UPC
0372205219304 0372205218307
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 ANDA218177 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (72205-218-30)
source: ndc

Packages (1)

72205-218-30 30 TABLET, FILM COATED in 1 BOTTLE (72205-218-30)

Ingredients (1)

prucalopride succinate (1 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": "89a7fce6-5d3e-4a71-a86c-06d209951c63", "openfda": {"upc": ["0372205219304", "0372205218307"], "unii": ["4V2G75E1CK"], "rxcui": ["2107345", "2107353"], "spl_set_id": ["1f195f1d-d509-4f8b-8710-2d0d110b6b5c"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72205-218-30)", "package_ndc": "72205-218-30", "marketing_start_date": "20250624"}], "brand_name": "PRUCALOPRIDE", "product_id": "72205-218_89a7fce6-5d3e-4a71-a86c-06d209951c63", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 4 Receptor Agonists [MoA]", "Serotonin-4 Receptor Agonist [EPC]"], "product_ndc": "72205-218", "generic_name": "PRUCALOPRIDE", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PRUCALOPRIDE", "active_ingredients": [{"name": "PRUCALOPRIDE SUCCINATE", "strength": "1 mg/1"}], "application_number": "ANDA218177", "marketing_category": "ANDA", "marketing_start_date": "20250624", "listing_expiration_date": "20271231"}