NDC 80425-0097

Gabapentin 600 mg tablet, film coated

On the label: Advanced Rx Pharmacy of Tennessee, LLC. It's repackaged: Advanced Rx Pharmacy of Tennessee, LLC rebottles it from Aurobindo Pharma Limited's NDC 65862-523.

India: 2United States: 1

Where the pills inside were made

FactoryWhereRoleLast FDA inspection
Apl Healthcare LimitedMahabubnagar, IndiaMakes it and tests it No problems foundJan 18, 2023 · 2 inspections
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

Repackaging site

Product details

Generic drug
Gabapentin: every company that makes it
Form
tablet, film coated, oral
Strength
600 mg
Approval
ANDA ANDA200651
On the market since
Oct 6, 2011
Package NDCs
80425-0097-1 80425-0097-2 80425-0097-3 80425-0097-4
Official label
DailyMed (National Library of Medicine), updated Dec 31, 2024

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