NDC 47335-537

Tramadol Hydrochloride 300 mg tablet, extended release

On the label: Caraco Pharmaceutical Laboratories, Ltd..

India: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Sun Pharmaceutical Industries LimitedHalol, IndiaMakes it and tests it Serious problems, FDA actionJun 13, 2025 · 12 inspections, 5 with FDA action

Product details

Generic drug
Tramadol: every company that makes it
Form
tablet, extended release, oral
Strength
300 mg
Approval
ANDA ANDA091607
On the market since
Dec 30, 2011
Package NDCs
47335-537-08 47335-537-18 47335-537-83 47335-537-88
Official label
DailyMed (National Library of Medicine), updated Dec 5, 2025

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