NDC 82009-097

Quetiapine fumarate 100 mg tablet

On the label: Quallent Pharmaceuticals Health LLC.

India: 2

Where it's made

FactoryWhereRoleLast FDA inspection
Lupin LimitedSalcette, IndiaMakes it and packages it Problems found, fixed voluntarilyNov 21, 2025 · 9 inspections, 1 with FDA action
Lupin LimitedPithampur, IndiaMakes it and packages it Serious problems, FDA actionJul 17, 2025 · 6 inspections, 4 with FDA action

Product details

Generic drug
Quetiapine: every company that makes it
Form
tablet, oral
Strength
100 mg
Approval
ANDA ANDA201109
On the market since
Jul 14, 2023
Package NDCs
82009-097-10
Official label
DailyMed (National Library of Medicine), updated Sep 1, 2026

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