prucalopride

Generic: prucalopride

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

Drug Facts

Product Profile

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

prucalopride succinate 1 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70748-389
Product ID 70748-389_b9640796-d193-4aff-b1d3-9399b0607d5c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218847
Listing Expiration 2027-12-31
Marketing Start 2025-06-25

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 70748389
Hyphenated Format 70748-389

Supplemental Identifiers

RxCUI
2107345 2107353
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 ANDA218847 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (70748-389-01)
source: ndc

Packages (1)

70748-389-01 30 TABLET, FILM COATED in 1 BOTTLE (70748-389-01)

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": "b9640796-d193-4aff-b1d3-9399b0607d5c", "openfda": {"unii": ["4V2G75E1CK"], "rxcui": ["2107345", "2107353"], "spl_set_id": ["124e8e82-972d-4800-9d68-14db416959b5"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70748-389-01)", "package_ndc": "70748-389-01", "marketing_start_date": "20250625"}], "brand_name": "Prucalopride", "product_id": "70748-389_b9640796-d193-4aff-b1d3-9399b0607d5c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 4 Receptor Agonists [MoA]", "Serotonin-4 Receptor Agonist [EPC]"], "product_ndc": "70748-389", "generic_name": "Prucalopride", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prucalopride", "active_ingredients": [{"name": "PRUCALOPRIDE SUCCINATE", "strength": "1 mg/1"}], "application_number": "ANDA218847", "marketing_category": "ANDA", "marketing_start_date": "20250625", "listing_expiration_date": "20271231"}