prucalopride succinate

Generic: prucalopride succinate

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prucalopride succinate
Generic Name prucalopride succinate
Labeler somerset therapeutics, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

prucalopride succinate 1 mg/1

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-821
Product ID 70069-821_7b3acc62-d656-47b8-91d2-5b30cd699fbd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219078
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 70069821
Hyphenated Format 70069-821

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 succinate (source: ndc)
Generic Name prucalopride succinate (source: ndc)
Application Number ANDA219078 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 BOTTLE (70069-821-01) / 30 TABLET in 1 BOTTLE
source: ndc

Packages (1)

70069-821-01 1 BOTTLE in 1 BOTTLE (70069-821-01) / 30 TABLET in 1 BOTTLE

Ingredients (1)

prucalopride succinate (1 mg/1)

Linked Drug Pages (1)

Prucalopride succinate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7b3acc62-d656-47b8-91d2-5b30cd699fbd", "openfda": {"unii": ["4V2G75E1CK"], "rxcui": ["2107345", "2107353"], "spl_set_id": ["1750cd94-b443-49df-9c53-eb5b68f66092"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOTTLE (70069-821-01)  / 30 TABLET in 1 BOTTLE", "package_ndc": "70069-821-01", "marketing_start_date": "20250624"}], "brand_name": "Prucalopride succinate", "product_id": "70069-821_7b3acc62-d656-47b8-91d2-5b30cd699fbd", "dosage_form": "TABLET", "pharm_class": ["Serotonin 4 Receptor Agonists [MoA]", "Serotonin-4 Receptor Agonist [EPC]"], "product_ndc": "70069-821", "generic_name": "Prucalopride succinate", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prucalopride succinate", "active_ingredients": [{"name": "PRUCALOPRIDE SUCCINATE", "strength": "1 mg/1"}], "application_number": "ANDA219078", "marketing_category": "ANDA", "marketing_start_date": "20250624", "listing_expiration_date": "20261231"}