NDC 15054-3301

Bylvay 200 ug capsule, coated pellets

On the label: Ipsen Biopharmaceuticals, Inc..

India: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Syngene International LimitedBengaluru, IndiaMakes the active ingredient and tests it No problems foundFeb 20, 2025 · 4 inspections
Almac Pharma Services LimitedCraigavon, United KingdomPackages it and labels it Problems found, fixed voluntarilyNov 28, 2025 · 8 inspections

Product details

Generic drug
Odevixibat: every company that makes it
Form
capsule, coated pellets, oral
Strength
200 ug
Approval
NDA NDA215498
On the market since
Jan 10, 2024
Package NDCs
15054-3301-1
Official label
DailyMed (National Library of Medicine), updated Dec 29, 2025

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