Package 85521-001-01

Brand: dandrx 1% ketoconazole anti-dandruff

Generic: dandrx 1% ketoconazole anti-dandruff shampoo
NDC Package

Package Facts

Identity

Package NDC 85521-001-01
Digits Only 8552100101
Product NDC 85521-001
Description

236 mL in 1 BOTTLE (85521-001-01)

Marketing

Marketing Status
Marketed Since 2025-04-09
Brand dandrx 1% ketoconazole anti-dandruff
Generic dandrx 1% ketoconazole anti-dandruff shampoo
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "324fb7bb-4b8f-e6e6-e063-6394a90adae1", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "unii": ["R9400W927I"], "rxcui": ["240812"], "spl_set_id": ["324fb7bb-4b8e-e6e6-e063-6394a90adae1"], "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": ["dandRX LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "236 mL in 1 BOTTLE (85521-001-01)", "package_ndc": "85521-001-01", "marketing_start_date": "20250409"}], "brand_name": "dandRX 1% Ketoconazole Anti-Dandruff", "product_id": "85521-001_324fb7bb-4b8f-e6e6-e063-6394a90adae1", "dosage_form": "LIQUID", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 3A5 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "85521-001", "generic_name": "dandRX 1% Ketoconazole Anti-Dandruff Shampoo", "labeler_name": "dandRX LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "dandRX 1% Ketoconazole Anti-Dandruff", "active_ingredients": [{"name": "KETOCONAZOLE", "strength": "1 g/100mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250409", "listing_expiration_date": "20261231"}