NDC 54868-4525

Elmiron 100 mg capsule, gelatin coated

On the label: Physicians Total Care, Inc.. It's repackaged: Physicians Total Care, Inc. rebottles it from Janssen Pharmaceuticals, Inc.'s NDC 50458-098.

United States: 1Germany: 1

Where the pills inside were made

FactoryWhereRoleLast FDA inspection
Janssen Ortho LLCGurabo, PR, United StatesMakes it and tests it Problems found, fixed voluntarilyMar 28, 2023 · 7 inspections
bene pharmaChem GmbH & Co. KGGeretsried, GermanyMakes the active ingredient Problems found, fixed voluntarilyNov 8, 2018 · 4 inspections

Product details

Generic drug
Pentosan Polysulfate: every company that makes it
Form
capsule, gelatin coated
Strength
100 mg
Approval
NDA NDA020193
On the market since
Dec 17, 2003
Package NDCs
50458-098-01 54868-4525-0 54868-4525-1 54868-4525-2 54868-4525-3
Official label
DailyMed (National Library of Medicine), updated Mar 8, 2010

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