NDC 68382-520

sirolimus 0.5 mg tablet, film coated

On the label: Zydus Pharmaceuticals (USA) Inc..

India: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Zydus Lifesciences LimitedAhmedabad, IndiaMakes it and tests it Problems found, fixed voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action

Product details

Generic drug
Sirolimus: every company that makes it
Form
tablet, film coated, oral
Strength
0.5 mg
Approval
ANDA ANDA201676
On the market since
Jan 15, 2014
Package NDCs
68382-520-01 68382-520-05 68382-520-06 68382-520-10 68382-520-16 68382-520-30 68382-520-77
Official label
DailyMed (National Library of Medicine), updated Jul 20, 2023

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