NDC 53002-4215

Sertraline Hydrochloride 100 mg tablet, film coated

On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Accord Healthcare Inc.'s NDC 16729-217.

India: 2

Where the pills inside were made

FactoryWhereRoleLast FDA inspection
Intas Pharmaceuticals LimitedAhmedabad, IndiaMakes it and tests it No problems foundJul 12, 2024 · 10 inspections
Intas Pharmaceuticals LimitedAhmedabad, IndiaMakes it and tests it Serious problems, FDA actionDec 2, 2022 · 7 inspections, 1 with FDA action

Repackaging site

Product details

Generic drug
Sertraline: every company that makes it
Form
tablet, film coated
Strength
100 mg
Approval
ANDA ANDA202825
On the market since
Feb 9, 2017
Package NDCs
53002-4215-0 53002-4215-3 53002-4215-6
Official label
DailyMed (National Library of Medicine), updated Mar 30, 2022

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