ketoconazole

Generic: ketoconazole

Labeler: cosette pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketoconazole
Generic Name ketoconazole
Labeler cosette pharmaceuticals, inc.
Dosage Form SHAMPOO, SUSPENSION
Routes
TOPICAL
Active Ingredients

ketoconazole 20 mg/mL

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0592
Product ID 0713-0592_2d7c8c0c-b20f-b41a-e063-6294a90af27c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076942
Listing Expiration 2026-12-31
Marketing Start 2025-02-07

Pharmacologic Class

Established (EPC)
azole antifungal [epc]
Mechanism of Action
cytochrome p450 3a4 inhibitors [moa] cytochrome p450 3a5 inhibitors [moa] p-glycoprotein inhibitors [moa]
Chemical Structure
azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130592
Hyphenated Format 0713-0592

Supplemental Identifiers

RxCUI
106336
UNII
R9400W927I
NUI
N0000175487 M0002083 N0000182141 N0000190115 N0000185503

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ketoconazole (source: ndc)
Generic Name ketoconazole (source: ndc)
Application Number ANDA076942 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE, PLASTIC (0713-0592-04)
source: ndc

Packages (1)

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

Ingredients (1)

ketoconazole (20 mg/mL)

Linked Drug Pages (1)

Ketoconazole ndc-match (0.9)

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"}