NDC 50458-290

Sporanox 100 mg capsule

On the label: Janssen Pharmaceuticals, Inc..

Belgium: 2United States: 1Ireland: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Janssen Ortho LLCGurabo, PR, United StatesMakes it Problems found, fixed voluntarilyMar 28, 2023 · 7 inspections
Janssen Pharmaceutica NVGeel, BelgiumMakes the active ingredient Problems found, fixed voluntarilyMar 26, 2024 · 7 inspections
Janssen Pharmaceutica NVOlen, BelgiumMakes it Problems found, fixed voluntarilyOct 7, 2025 · 5 inspections
Janssen Pharmaceutical Sciences Unlimited CompanyCo Cork, IrelandMakes the active ingredient Problems found, fixed voluntarilyOct 27, 2023 · 5 inspections
AndersonBrecon Inc.Rockford, IL, United StatesPackages it No problems foundAug 19, 2026 · 11 inspections

Product details

Generic drug
Itraconazole: every company that makes it
Form
capsule, oral
Strength
100 mg
Approval
NDA NDA020083
On the market since
Sep 11, 1992
Package NDCs
50458-290-01 50458-290-04 50458-290-28
Official label
DailyMed (National Library of Medicine), updated Jul 13, 2026

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