NDC 61269-475

Xeloda 500 mg tablet, film coated

On the label: H2-Pharma LLC.

Germany: 1Italy: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Excella GmbH & Co. KGFeucht, GermanyMakes it, tests it, packages it and labels it Problems found, fixed voluntarilyOct 19, 2022 · 7 inspections
F.i.s. Fabbrica Italiana Sintetici S.p.a.Montecchio Maggiore, ItalyMakes the active ingredient and tests it Problems found, fixed voluntarilyMar 6, 2026 · 7 inspections
F. Hoffmann-La Roche AGKaiseraugst, SwitzerlandTests it Problems found, fixed voluntarilyMar 21, 2025 · 8 inspections
F. Hoffmann-La Roche AGBasel, SwitzerlandTests it Problems found, fixed voluntarilyMay 9, 2025 · 9 inspections

Product details

Generic drug
Capecitabine: every company that makes it
Form
tablet, film coated, oral
Strength
500 mg
Approval
NDA NDA020896
On the market since
Apr 30, 1998
Package NDCs
61269-475-12
Official label
DailyMed (National Library of Medicine), updated Feb 5, 2026

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