prucalopride

Generic: prucalopride

Labeler: ajanta pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prucalopride
Generic Name prucalopride
Labeler ajanta pharma usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

prucalopride 2 mg/1

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-295
Product ID 27241-295_ac2afe93-a78a-4dfe-8759-fec53f872e35
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219220
Listing Expiration 2027-12-31
Marketing Start 2026-01-16

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 27241295
Hyphenated Format 27241-295

Supplemental Identifiers

RxCUI
2107345 2107353
UPC
0327241294303 0327241295300
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 ANDA219220 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (27241-295-30)
source: ndc

Packages (1)

27241-295-30 30 TABLET in 1 BOTTLE (27241-295-30)

Ingredients (1)

prucalopride (2 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": "ac2afe93-a78a-4dfe-8759-fec53f872e35", "openfda": {"nui": ["N0000193871", "N0000193870"], "upc": ["0327241294303", "0327241295300"], "unii": ["0A09IUW5TP"], "rxcui": ["2107345", "2107353"], "spl_set_id": ["c9d7152d-b117-4346-b60c-dc87b59ead09"], "pharm_class_epc": ["Serotonin-4 Receptor Agonist [EPC]"], "pharm_class_moa": ["Serotonin 4 Receptor Agonists [MoA]"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (27241-295-30)", "package_ndc": "27241-295-30", "marketing_start_date": "20260116"}], "brand_name": "Prucalopride", "product_id": "27241-295_ac2afe93-a78a-4dfe-8759-fec53f872e35", "dosage_form": "TABLET", "pharm_class": ["Serotonin 4 Receptor Agonists [MoA]", "Serotonin-4 Receptor Agonist [EPC]"], "product_ndc": "27241-295", "generic_name": "Prucalopride", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prucalopride", "active_ingredients": [{"name": "PRUCALOPRIDE", "strength": "2 mg/1"}], "application_number": "ANDA219220", "marketing_category": "ANDA", "marketing_start_date": "20260116", "listing_expiration_date": "20271231"}