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Active ingredient

Prucalopride

38 finished FDA listings contain Prucalopride as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
PRUCALOPRIDE, PRUCALOPRIDE SUCCINATE
Dosage forms
Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
19
Strengths listed
1 mg/1 · 2 mg/1
Brand names in FDA listings
Motegrity

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 2107310

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 210166TAKEDA PHARMS USA2018-12-142
ANDA 218492NOVITIUM PHARMA2024-12-262
ANDA 218795ZENARA2025-06-242
ANDA 219078SOMERSET THERAP2025-06-242
ANDA 218977APOTEX2025-06-244
ANDA 218847LUPIN2025-06-242
ANDA 217662HIKMA2025-06-242
ANDA 218177MSN2025-06-242
ANDA 218963APPCO2025-06-242
ANDA 218812AMNEAL2025-06-244
ANDA 219160ANNORA PHARMA2025-06-242
ANDA 219193SPECGX LLC2025-06-242
ANDA 218056ZYDUS LIFESCIENCES2025-08-074
ANDA 219220AJANTA PHARMA LTD2026-01-162
ANDA 219234ALEMBIC2026-07-274

Official labeling on DailyMed

Showing the 12 most recent of 18 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.