NDC 82009-102

Fluoxetine 40 mg capsule

On the label: Quallent Pharmaceuticals Health LLC.

India: 3

Where it's made

FactoryWhereRoleLast FDA inspection
Apl Healthcare LimitedTirupati, IndiaMakes it and tests it Problems found, fixed voluntarilyDec 17, 2025 · 5 inspections
Aurobindo Pharma LimitedMedchal, IndiaMakes it and tests it Problems found, fixed voluntarilyJul 21, 2023 · 13 inspections, 1 with FDA action
Aurobindo Pharma LimitedMahabubnagar, IndiaMakes it and tests it Problems found, fixed voluntarilyMay 10, 2022 · 7 inspections, 1 with FDA action

Product details

Generic drug
Fluoxetine: every company that makes it
Form
capsule, oral
Strength
40 mg
Approval
ANDA ANDA078619
On the market since
Sep 1, 2023
Package NDCs
82009-102-05
Official label
DailyMed (National Library of Medicine), updated Aug 20, 2025

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