NDC 69097-030

Nilotinib 50 mg capsule

On the label: Cipla USA., Inc..

India: 2Canada: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Cipla LimitedSalcette, IndiaMakes it and tests it Problems found, fixed voluntarilyJun 21, 2024 · 12 inspections, 2 with FDA action
Cipla LimitedBengaluru, IndiaMakes the active ingredient Problems found, fixed voluntarilyMay 30, 2025 · 4 inspections
Genvion CorporationWinnipeg, CanadaMakes it and tests it Problems found, fixed voluntarilyJul 28, 2023 · 2 inspections

Product details

Generic drug
Nilotinib: every company that makes it
Form
capsule, oral
Strength
50 mg
Approval
NDA NDA218922
On the market since
Jun 18, 2025
Package NDCs
69097-030-08 69097-030-16 69097-030-63
Official label
DailyMed (National Library of Medicine), updated Sep 29, 2026

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