Package 51862-462-60

Brand: tolsura

Generic: itraconazole
NDC Package

Package Facts

Identity

Package NDC 51862-462-60
Digits Only 5186246260
Product NDC 51862-462
Description

60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (51862-462-60)

Marketing

Marketing Status
Marketed Since 2018-12-11
Brand tolsura
Generic itraconazole
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "2a3303f1-eee7-4c07-9532-e153be149369", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000185503", "N0000190113"], "upc": ["0351862462605"], "unii": ["304NUG5GF4"], "rxcui": ["2106642", "2106648"], "spl_set_id": ["306352d1-9d5a-49ad-b72d-893b99546861"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "pharm_class_moa": ["Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]"], "manufacturer_name": ["Mayne Pharma Commercial LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (51862-462-60)", "package_ndc": "51862-462-60", "marketing_start_date": "20181211"}], "brand_name": "Tolsura", "product_id": "51862-462_2a3303f1-eee7-4c07-9532-e153be149369", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "51862-462", "generic_name": "Itraconazole", "labeler_name": "Mayne Pharma Commercial LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tolsura", "active_ingredients": [{"name": "ITRACONAZOLE", "strength": "65 mg/1"}], "application_number": "NDA208901", "marketing_category": "NDA", "marketing_start_date": "20181211", "listing_expiration_date": "20261231"}