Package 50419-422-01
Brand: skyla
Generic: levonorgestrelPackage Facts
Identity
Package NDC
50419-422-01
Digits Only
5041942201
Product NDC
50419-422
Description
1 INTRAUTERINE DEVICE in 1 CARTON (50419-422-01)
Marketing
Marketing Status
Brand
skyla
Generic
levonorgestrel
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAUTERINE"], "spl_id": "01b52e09-d273-4503-8589-a2bb64c1574c", "openfda": {"nui": ["N0000175830", "M0447349", "N0000175602", "N0000175832"], "unii": ["5W7SIA7YZW"], "rxcui": ["1366334", "1366339"], "spl_set_id": ["9f44ff35-e052-49cd-a1c2-0bfd87d49309"], "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 (50419-422-01)", "package_ndc": "50419-422-01", "marketing_start_date": "20130111"}, {"sample": false, "description": "1 INTRAUTERINE DEVICE in 1 CARTON (50419-422-08)", "package_ndc": "50419-422-08", "marketing_start_date": "20130111"}], "brand_name": "Skyla", "product_id": "50419-422_01b52e09-d273-4503-8589-a2bb64c1574c", "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": "50419-422", "generic_name": "Levonorgestrel", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Skyla", "active_ingredients": [{"name": "LEVONORGESTREL", "strength": "13.5 mg/1"}], "application_number": "NDA203159", "marketing_category": "NDA", "marketing_start_date": "20130111", "listing_expiration_date": "20271231"}