ketoconazole

Generic: ketoconazole

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketoconazole
Generic Name ketoconazole
Labeler a-s medication solutions
Dosage Form SHAMPOO, SUSPENSION
Routes
TOPICAL
Active Ingredients

ketoconazole 20 mg/mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7538
Product ID 50090-7538_6e43133e-cf9e-454c-aeab-12fba2eff208
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 500907538
Hyphenated Format 50090-7538

Supplemental Identifiers

RxCUI
106336
UNII
R9400W927I
NUI
N0000175487 M0002083 N0000182141 N0000190115 N0000185503

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 (50090-7538-0)
source: ndc

Packages (1)

50090-7538-0 120 mL in 1 BOTTLE, PLASTIC (50090-7538-0)

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": "6e43133e-cf9e-454c-aeab-12fba2eff208", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "unii": ["R9400W927I"], "rxcui": ["106336"], "spl_set_id": ["a884bad7-df8c-45de-8c4f-42034b40e425"], "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": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE, PLASTIC (50090-7538-0)", "package_ndc": "50090-7538-0", "marketing_start_date": "20250421"}], "brand_name": "Ketoconazole", "product_id": "50090-7538_6e43133e-cf9e-454c-aeab-12fba2eff208", "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": "50090-7538", "generic_name": "Ketoconazole", "labeler_name": "A-S Medication Solutions", "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"}