prucalopride

Generic: prucalopride

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prucalopride
Generic Name prucalopride
Labeler ani pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

prucalopride succinate 1 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-596
Product ID 70954-596_a33b876a-c96e-4f3d-a1b8-56c4daa46892
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218492
Listing Expiration 2026-12-31
Marketing Start 2024-12-26

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 70954596
Hyphenated Format 70954-596

Supplemental Identifiers

RxCUI
2107345 2107353
UPC
0370954597100 0370954596103
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 ANDA218492 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (70954-596-10)
source: ndc

Packages (1)

70954-596-10 30 TABLET in 1 BOTTLE (70954-596-10)

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": "a33b876a-c96e-4f3d-a1b8-56c4daa46892", "openfda": {"upc": ["0370954597100", "0370954596103"], "unii": ["4V2G75E1CK"], "rxcui": ["2107345", "2107353"], "spl_set_id": ["6d82dfbd-f171-4045-9f7a-268e189a658a"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (70954-596-10)", "package_ndc": "70954-596-10", "marketing_start_date": "20241226"}], "brand_name": "Prucalopride", "product_id": "70954-596_a33b876a-c96e-4f3d-a1b8-56c4daa46892", "dosage_form": "TABLET", "pharm_class": ["Serotonin 4 Receptor Agonists [MoA]", "Serotonin-4 Receptor Agonist [EPC]"], "product_ndc": "70954-596", "generic_name": "Prucalopride", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prucalopride", "active_ingredients": [{"name": "PRUCALOPRIDE SUCCINATE", "strength": "1 mg/1"}], "application_number": "ANDA218492", "marketing_category": "ANDA", "marketing_start_date": "20241226", "listing_expiration_date": "20261231"}