NDC 65862-574

Montelukast Sodium 10 mg tablet, film coated

On the label: Aurobindo Pharma Limited.

India: 1United States: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Aurobindo Pharma LimitedMahabubnagar, IndiaMakes it and tests it Problems found, fixed voluntarilyMay 10, 2022 · 7 inspections, 1 with FDA action
Aurolife Pharma LLCDayton, NJ, United StatesMakes it and tests it Serious problems, FDA actionDec 7, 2021 · 10 inspections, 1 with FDA action
Aurolife Pharma LLCDayton, NJ, United StatesPackages it and labels it Serious problems, FDA actionDec 7, 2021 · 10 inspections, 1 with FDA action

Product details

Generic drug
Montelukast: every company that makes it
Form
tablet, film coated, oral
Strength
10 mg
Approval
ANDA ANDA202468
On the market since
Aug 3, 2012
Package NDCs
65862-574-10 65862-574-19 65862-574-30 65862-574-66 65862-574-90
Official label
DailyMed (National Library of Medicine), updated Aug 31, 2026

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