NDC 13668-081

Montelukast Sodium 10 mg tablet

On the label: Torrent Pharma, Inc..

India: 2

Where it's made

FactoryWhereRoleLast FDA inspection
Torrent Pharmaceuticals LimitedIndrad, IndiaMakes it, makes the active ingredient, tests it and packages it Problems found, fixed voluntarilyJun 12, 2024 · 7 inspections, 2 with FDA action
Torrent Pharmaceuticals LimitedBharuch, IndiaMakes it, makes the active ingredient, tests it and packages it No problems foundJan 23, 2026 · 5 inspections, 1 with FDA action

Product details

Generic drug
Montelukast: every company that makes it
Form
tablet, oral
Strength
10 mg
Approval
ANDA ANDA201515
On the market since
Aug 3, 2012
Package NDCs
13668-081-05 13668-081-30 13668-081-32 13668-081-74 13668-081-90
Official label
DailyMed (National Library of Medicine), updated Jul 28, 2026

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