Package 80584-103-01

Brand: restart

Generic: levonorgestrel
NDC Package

Package Facts

Identity

Package NDC 80584-103-01
Digits Only 8058410301
Product NDC 80584-103
Description

1 BLISTER PACK in 1 CARTON (80584-103-01) / 1 TABLET in 1 BLISTER PACK

Marketing

Marketing Status
Marketed Since 2024-10-08
Brand restart
Generic levonorgestrel
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "3d594e56-b2b5-8a28-e063-6394a90a20e1", "openfda": {"nui": ["N0000175830", "M0447349", "N0000175602", "N0000175832"], "unii": ["5W7SIA7YZW"], "rxcui": ["483325", "2722270"], "spl_set_id": ["0cdf198e-c114-b9fa-e063-6294a90a566a"], "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": ["Winx Health Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (80584-103-01)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "80584-103-01", "marketing_start_date": "20241008"}], "brand_name": "Restart", "product_id": "80584-103_3d594e56-b2b5-8a28-e063-6394a90a20e1", "dosage_form": "TABLET", "pharm_class": ["Inhibit Ovum Fertilization [PE]", "Progesterone Congeners [CS]", "Progesterone Congeners [CS]", "Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]"], "product_ndc": "80584-103", "generic_name": "Levonorgestrel", "labeler_name": "Winx Health Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Restart", "active_ingredients": [{"name": "LEVONORGESTREL", "strength": "1.5 mg/1"}], "application_number": "ANDA207660", "marketing_category": "ANDA", "marketing_start_date": "20241008", "listing_expiration_date": "20261231"}