NDC 67046-555

Sertraline Hydrochloride 50 mg tablet, film coated

On the label: Coupler Enterprises Inc.. It's repackaged: Coupler Enterprises Inc. rebottles it from Aurobindo Pharma Limited's NDC 65862-012.

India: 3

Where the pills inside were 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

Repackaging site

Product details

Generic drug
Sertraline: every company that makes it
Form
tablet, film coated
Strength
50 mg
Approval
ANDA ANDA077206
On the market since
Sep 15, 2020
Package NDCs
67046-555-30
Official label
DailyMed (National Library of Medicine), updated Sep 28, 2020

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