prucalopride

Generic: prucalopride

Labeler: specgx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

prucalopride 1 mg/1

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-6301
Product ID 0406-6301_ef151ce8-6bd9-4be8-9010-337ad85551b1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219193
Listing Expiration 2027-12-31
Marketing Start 2025-06-24

Pharmacologic Class

Established (EPC)
serotonin-4 receptor agonist [epc]
Mechanism of Action
serotonin 4 receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04066301
Hyphenated Format 0406-6301

Supplemental Identifiers

RxCUI
2107345 2107353
UPC
0304066302031 0304066301034
UNII
0A09IUW5TP
NUI
N0000193871 N0000193870

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 ANDA219193 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0406-6301-03)
source: ndc

Packages (1)

0406-6301-03 30 TABLET, FILM COATED in 1 BOTTLE (0406-6301-03)

Ingredients (1)

prucalopride (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": "ef151ce8-6bd9-4be8-9010-337ad85551b1", "openfda": {"nui": ["N0000193871", "N0000193870"], "upc": ["0304066302031", "0304066301034"], "unii": ["0A09IUW5TP"], "rxcui": ["2107345", "2107353"], "spl_set_id": ["70fced73-c25b-46cb-ad30-19328e6130c3"], "pharm_class_epc": ["Serotonin-4 Receptor Agonist [EPC]"], "pharm_class_moa": ["Serotonin 4 Receptor Agonists [MoA]"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0406-6301-03)", "package_ndc": "0406-6301-03", "marketing_start_date": "20250624"}], "brand_name": "Prucalopride", "product_id": "0406-6301_ef151ce8-6bd9-4be8-9010-337ad85551b1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 4 Receptor Agonists [MoA]", "Serotonin-4 Receptor Agonist [EPC]"], "product_ndc": "0406-6301", "generic_name": "Prucalopride", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prucalopride", "active_ingredients": [{"name": "PRUCALOPRIDE", "strength": "1 mg/1"}], "application_number": "ANDA219193", "marketing_category": "ANDA", "marketing_start_date": "20250624", "listing_expiration_date": "20271231"}