NDC 33261-417

Ondansetron Hydrochloride 4 mg tablet, film coated

On the label: Aidarex Pharmaceuticals LLC. It's repackaged: Aidarex Pharmaceuticals LLC rebottles it from Aurobindo Pharma Limited's NDC 65862-187.

India: 1

Where the pills inside were made

FactoryWhereRoleLast FDA inspection
Aurobindo Pharma LimitedMedchal, IndiaMakes it and tests it Problems found, fixed voluntarilyJul 21, 2023 · 13 inspections, 1 with FDA action

Recalls

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug
Ondansetron: every company that makes it
Form
tablet, film coated
Strength
4 mg
Approval
ANDA ANDA078539
On the market since
Jul 31, 2007
Package NDCs
33261-417-05 33261-417-06 33261-417-09 33261-417-10 33261-417-12 33261-417-15 33261-417-20 33261-417-30
Official label
DailyMed (National Library of Medicine), updated Jan 21, 2014

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