ketodan

Generic: ketoconazole

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

Drug Facts

Product Profile

Brand Name ketodan
Generic Name ketoconazole
Labeler medimetriks pharmaceuticals, inc.
Dosage Form AEROSOL, FOAM
Routes
TOPICAL
Active Ingredients

ketoconazole 20 mg/g

Manufacturer
Medimetriks Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43538-530
Product ID 43538-530_354d4926-b665-4e7e-a86a-5baae165a470
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091550
Listing Expiration 2026-12-31
Marketing Start 2012-06-15

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 43538530
Hyphenated Format 43538-530

Supplemental Identifiers

RxCUI
728550 1300272
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 ketodan (source: ndc)
Generic Name ketoconazole (source: ndc)
Application Number ANDA091550 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 1 CAN in 1 CARTON (43538-530-10) / 100 g in 1 CAN
source: ndc

Packages (1)

43538-530-10 1 CAN in 1 CARTON (43538-530-10) / 100 g in 1 CAN

Ingredients (1)

ketoconazole (20 mg/g)

Linked Drug Pages (1)

Ketodan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "354d4926-b665-4e7e-a86a-5baae165a470", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "unii": ["R9400W927I"], "rxcui": ["728550", "1300272"], "spl_set_id": ["62f19bd8-926e-4e6b-9097-d81b894b95cc"], "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": ["Medimetriks Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CAN in 1 CARTON (43538-530-10)  / 100 g in 1 CAN", "package_ndc": "43538-530-10", "marketing_start_date": "20120615"}], "brand_name": "Ketodan", "product_id": "43538-530_354d4926-b665-4e7e-a86a-5baae165a470", "dosage_form": "AEROSOL, FOAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 3A5 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "43538-530", "generic_name": "ketoconazole", "labeler_name": "Medimetriks Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketodan", "active_ingredients": [{"name": "KETOCONAZOLE", "strength": "20 mg/g"}], "application_number": "ANDA091550", "marketing_category": "ANDA", "marketing_start_date": "20120615", "listing_expiration_date": "20261231"}