NDC 68462-682

sirolimus 0.5 mg tablet, film coated

On the label: Glenmark Pharmaceuticals Inc., USA.

India: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Glenmark Pharmaceuticals LimitedDhar, IndiaMakes it and tests it Serious problems, FDA actionFeb 14, 2025 · 8 inspections, 1 with FDA action

Product details

Generic drug
Sirolimus: every company that makes it
Form
tablet, film coated, oral
Strength
0.5 mg
Approval
ANDA ANDA208691
On the market since
Oct 16, 2020
Package NDCs
68462-682-01
Official label
DailyMed (National Library of Medicine), updated Jan 28, 2026

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