Manufacturing Establishments3
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bayer Pharma Oy
Bayer HealthCare Pharmaceuticals Inc.
369758383
Sterigenics Belgium Petit-Rechain S.A.
Bayer HealthCare Pharmaceuticals Inc.
370026481
Bayer AG
Bayer HealthCare Pharmaceuticals Inc.
342872971
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mirena
Product Details
NDC Product Code
50419-423Application Number
NDA021225Marketing Category
NDA (C73594)Route of Administration
INTRAUTERINEEffective Date
December 21, 2016LevonorgestrelActive
Code: 5W7SIA7YZWClass: ACTIBQuantity: 52 mg in 1 1
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
BARIUM SULFATEInactive
Code: 25BB7EKE2EClass: IACT