 
                        | Product NDC: | 50419-421 | 
| Proprietary Name: | Mirena | 
| Non Proprietary Name: | Levonorgestrel | 
| Active Ingredient(s): | 52 mg/1 & nbsp; Levonorgestrel | 
| Administration Route(s): | INTRAUTERINE | 
| Dosage Form(s): | INTRAUTERINE DEVICE | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 50419-421 | 
| Labeler Name: | Bayer HealthCare Pharmaceuticals Inc. | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | NDA021225 | 
| Marketing Category: | NDA | 
| Start Marketing Date: | 20091001 | 
| Package NDC: | 50419-421-01 | 
| Package Description: | 1 INTRAUTERINE DEVICE in 1 CARTON (50419-421-01) | 
| NDC Code | 50419-421-01 | 
| Proprietary Name | Mirena | 
| Package Description | 1 INTRAUTERINE DEVICE in 1 CARTON (50419-421-01) | 
| Product NDC | 50419-421 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | Levonorgestrel | 
| Dosage Form Name | INTRAUTERINE DEVICE | 
| Route Name | INTRAUTERINE | 
| Start Marketing Date | 20091001 | 
| Marketing Category Name | NDA | 
| Labeler Name | Bayer HealthCare Pharmaceuticals Inc. | 
| Substance Name | LEVONORGESTREL | 
| Strength Number | 52 | 
| Strength Unit | mg/1 | 
| Pharmaceutical Classes | Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] |