Package 0054-0749-13

Brand: prucalopride

Generic: prucalopride
NDC Package

Package Facts

Identity

Package NDC 0054-0749-13
Digits Only 0054074913
Product NDC 0054-0749
Description

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

Marketing

Marketing Status
Marketed Since 2025-06-24
Brand prucalopride
Generic prucalopride
Sample Package No

Linked Drug Pages (1)

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"}