motegrity

Generic: prucalopride

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

prucalopride succinate 2 mg/1

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 54092-547
Product ID 54092-547_1278ace1-66f8-4bd8-8cf0-bd731f936563
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210166
Listing Expiration 2026-12-31
Marketing Start 2018-12-14

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 54092547
Hyphenated Format 54092-547

Supplemental Identifiers

RxCUI
2107345 2107351 2107353 2107355
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 motegrity (source: ndc)
Generic Name prucalopride (source: ndc)
Application Number NDA210166 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (54092-547-01)
source: ndc

Packages (1)

54092-547-01 30 TABLET, FILM COATED in 1 BOTTLE (54092-547-01)

Ingredients (1)

prucalopride succinate (2 mg/1)

Linked Drug Pages (1)

MOTEGRITY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1278ace1-66f8-4bd8-8cf0-bd731f936563", "openfda": {"unii": ["4V2G75E1CK"], "rxcui": ["2107345", "2107351", "2107353", "2107355"], "spl_set_id": ["bca1e4c6-4b2b-4876-8ab3-654629c4ff1b"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (54092-547-01)", "package_ndc": "54092-547-01", "marketing_start_date": "20181214"}], "brand_name": "MOTEGRITY", "product_id": "54092-547_1278ace1-66f8-4bd8-8cf0-bd731f936563", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 4 Receptor Agonists [MoA]", "Serotonin-4 Receptor Agonist [EPC]"], "product_ndc": "54092-547", "generic_name": "PRUCALOPRIDE", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MOTEGRITY", "active_ingredients": [{"name": "PRUCALOPRIDE SUCCINATE", "strength": "2 mg/1"}], "application_number": "NDA210166", "marketing_category": "NDA", "marketing_start_date": "20181214", "listing_expiration_date": "20261231"}