Package 0713-0592-04

Brand: ketoconazole

Generic: ketoconazole
NDC Package

Package Facts

Identity

Package NDC 0713-0592-04
Digits Only 0713059204
Product NDC 0713-0592
Description

120 mL in 1 BOTTLE, PLASTIC (0713-0592-04)

Marketing

Marketing Status
Marketed Since 2025-02-07
Brand ketoconazole
Generic ketoconazole
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "2d7c8c0c-b20f-b41a-e063-6294a90af27c", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "unii": ["R9400W927I"], "rxcui": ["106336"], "spl_set_id": ["2d7c8dd1-59b5-2645-e063-6394a90a5bda"], "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": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE, PLASTIC (0713-0592-04)", "package_ndc": "0713-0592-04", "marketing_start_date": "20250207"}], "brand_name": "Ketoconazole", "product_id": "0713-0592_2d7c8c0c-b20f-b41a-e063-6294a90af27c", "dosage_form": "SHAMPOO, SUSPENSION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 3A5 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "0713-0592", "generic_name": "Ketoconazole", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketoconazole", "active_ingredients": [{"name": "KETOCONAZOLE", "strength": "20 mg/mL"}], "application_number": "ANDA076942", "marketing_category": "ANDA", "marketing_start_date": "20250207", "listing_expiration_date": "20261231"}