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] |