Package 50419-424-01
Brand: kyleena
Generic: levonorgestrelPackage Facts
Identity
Package NDC
50419-424-01
Digits Only
5041942401
Product NDC
50419-424
Description
1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-01)
Marketing
Marketing Status
Brand
kyleena
Generic
levonorgestrel
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAUTERINE"], "spl_id": "e22aea7f-9d28-426d-879a-4723fa76f2c2", "openfda": {"nui": ["N0000175830", "M0447349", "N0000175602", "N0000175832"], "unii": ["5W7SIA7YZW"], "rxcui": ["1811886", "1856546"], "spl_set_id": ["2e07c155-21e1-4781-9633-ce8bddd47080"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_pe": ["Inhibit Ovum Fertilization [PE]"], "pharm_class_epc": ["Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-01)", "package_ndc": "50419-424-01", "marketing_start_date": "20160919"}, {"sample": false, "description": "1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-08)", "package_ndc": "50419-424-08", "marketing_start_date": "20160919"}, {"sample": true, "description": "1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-71)", "package_ndc": "50419-424-71", "marketing_start_date": "20160919"}], "brand_name": "Kyleena", "product_id": "50419-424_e22aea7f-9d28-426d-879a-4723fa76f2c2", "dosage_form": "INTRAUTERINE DEVICE", "pharm_class": ["Inhibit Ovum Fertilization [PE]", "Progesterone Congeners [CS]", "Progesterone Congeners [CS]", "Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]"], "product_ndc": "50419-424", "generic_name": "Levonorgestrel", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Kyleena", "active_ingredients": [{"name": "LEVONORGESTREL", "strength": "19.5 mg/1"}], "application_number": "NDA208224", "marketing_category": "NDA", "marketing_start_date": "20160919", "listing_expiration_date": "20261231"}