| 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] |