prucalopride

Generic: prucalopride

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

Drug Facts

Product Profile

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

prucalopride succinate 1 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc

Identifiers & Regulatory

Product NDC 0054-0749
Product ID 0054-0749_e912e1b4-48aa-472d-b6c4-d1f769cff5e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217662
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 00540749
Hyphenated Format 0054-0749

Supplemental Identifiers

RxCUI
2107345 2107353
UPC
0300540749132 0300540750138
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 ANDA217662 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0054-0749-13)
source: ndc

Packages (1)

0054-0749-13 30 TABLET, FILM COATED in 1 BOTTLE (0054-0749-13)

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": "e912e1b4-48aa-472d-b6c4-d1f769cff5e2", "openfda": {"upc": ["0300540749132", "0300540750138"], "unii": ["4V2G75E1CK"], "rxcui": ["2107345", "2107353"], "spl_set_id": ["e1e9e36c-ce5a-4323-9d20-395bb5e80e64"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0054-0749-13)", "package_ndc": "0054-0749-13", "marketing_start_date": "20250624"}], "brand_name": "Prucalopride", "product_id": "0054-0749_e912e1b4-48aa-472d-b6c4-d1f769cff5e2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 4 Receptor Agonists [MoA]", "Serotonin-4 Receptor Agonist [EPC]"], "product_ndc": "0054-0749", "generic_name": "Prucalopride", "labeler_name": "Hikma Pharmaceuticals USA Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prucalopride", "active_ingredients": [{"name": "PRUCALOPRIDE SUCCINATE", "strength": "1 mg/1"}], "application_number": "ANDA217662", "marketing_category": "ANDA", "marketing_start_date": "20250624", "listing_expiration_date": "20261231"}