NDC 42571-459

varenicline tartrate 0.5 mg tablet, film coated

On the label: Micro Labs Limited.

India: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Micro Labs LimitedVerna, IndiaMakes it, tests it, packages it and labels it Problems found, fixed voluntarilyMay 30, 2025 · 6 inspections, 1 with FDA action

Product details

Generic drug
Varenicline: every company that makes it
Form
tablet, film coated, oral
Strength
0.5 mg
Approval
ANDA ANDA218302
On the market since
Dec 1, 2025
Package NDCs
42571-459-82
Official label
DailyMed (National Library of Medicine), updated Oct 31, 2025

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