NDC 0054-0750

Prucalopride 2 mg tablet, film coated

On the label: Hikma Pharmaceuticals USA Inc..

India: 1United States: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Shilpa Pharma Lifesciences LimitedRaichur, IndiaMakes the active ingredient No problems foundMar 14, 2025 · 6 inspections, 1 with FDA action
West-Ward Columbus Inc.Columbus, OH, United StatesMakes it No problems foundApr 30, 2026 · 27 inspections

Product details

Generic drug
Prucalopride: every company that makes it
Form
tablet, film coated, oral
Strength
2 mg
Approval
ANDA ANDA217662
On the market since
Jun 24, 2025
Package NDCs
0054-0750-13
Official label
DailyMed (National Library of Medicine), updated Nov 3, 2025

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