NDC 50419-423

Mirena 52 mg intrauterine device

On the label: Bayer HealthCare Pharmaceuticals Inc..

Germany: 1Finland: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Bayer AGBergkamen, GermanyMakes the active ingredient and tests it Problems found, fixed voluntarilyNov 14, 2024 · 7 inspections, 1 with FDA action
Bayer OyTurku, FinlandMakes it, tests it, packages it, labels it and sterilizes it Problems found, fixed voluntarilySep 15, 2023 · 5 inspections
Bayer AktiengesellschaftBerlin, GermanyTests it and mills it Problems found, fixed voluntarilyJun 16, 2023 · 5 inspections
Sterigenics Belgium (Petit Rechain) SRLVerviers, BelgiumSterilizes it Problems found, fixed voluntarilyJun 29, 2023 · 3 inspections

Product details

Generic drug
Levonorgestrel: every company that makes it
Form
intrauterine device, intrauterine
Strength
52 mg
Approval
NDA NDA021225
On the market since
Oct 1, 2009
Package NDCs
50419-423-01 50419-423-08
Official label
DailyMed (National Library of Medicine), updated Oct 29, 2025

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