Package 85384-0001-1

Brand: 1% ketoconazole

Generic: ketoconazole
NDC Package

Package Facts

Identity

Package NDC 85384-0001-1
Digits Only 8538400011
Product NDC 85384-0001
Product ID 85384-0001_30b75584-3a1f-c125-e063-6294a90acaa7
Description

250 mL in 1 BOTTLE (85384-0001-1)

Marketing

Marketing Status
Marketed Since 2025-03-31
Brand 1% ketoconazole
Generic ketoconazole
Sample Package No

Linked Drug Pages (1)

1% ketoconazole ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "30b75584-3a1f-c125-e063-6294a90acaa7", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "unii": ["R9400W927I"], "rxcui": ["240812"], "spl_set_id": ["30b75584-3a1e-c125-e063-6294a90acaa7"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "pharm_class_moa": ["Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 3A5 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["TAGRID LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "250 mL in 1 BOTTLE (85384-0001-1)", "package_ndc": "85384-0001-1", "marketing_start_date": "20250331"}], "brand_name": "1% ketoconazole", "product_id": "85384-0001_30b75584-3a1f-c125-e063-6294a90acaa7", "dosage_form": "SHAMPOO", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 3A5 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "85384-0001", "generic_name": "Ketoconazole", "labeler_name": "TAGRID LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "1% ketoconazole", "active_ingredients": [{"name": "KETOCONAZOLE", "strength": "10 mg/mL"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250331", "listing_expiration_date": "20261231"}