ketoconazole

Generic: ketoconazole

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketoconazole
Generic Name ketoconazole
Labeler padagis israel pharmaceuticals ltd
Dosage Form AEROSOL, FOAM
Routes
TOPICAL
Active Ingredients

ketoconazole 2 g/100g

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-532
Product ID 45802-532_f9768109-216c-49f3-be2a-d0c3eac142b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091550
Listing Expiration 2026-12-31
Marketing Start 2011-08-30

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 45802532
Hyphenated Format 45802-532

Supplemental Identifiers

RxCUI
728550
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 ANDA091550 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2 g/100g
source: ndc
Packaging
  • 1 CANISTER in 1 CARTON (45802-532-32) / 50 g in 1 CANISTER
  • 1 CANISTER in 1 CARTON (45802-532-33) / 100 g in 1 CANISTER
source: ndc

Packages (2)

45802-532-32 1 CANISTER in 1 CARTON (45802-532-32) / 50 g in 1 CANISTER 45802-532-33 1 CANISTER in 1 CARTON (45802-532-33) / 100 g in 1 CANISTER

Ingredients (1)

ketoconazole (2 g/100g)

Linked Drug Pages (1)

ketoconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "f9768109-216c-49f3-be2a-d0c3eac142b9", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "unii": ["R9400W927I"], "rxcui": ["728550"], "spl_set_id": ["9b65f632-a98d-400e-9ec3-84dea581d6a3"], "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": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CANISTER in 1 CARTON (45802-532-32)  / 50 g in 1 CANISTER", "package_ndc": "45802-532-32", "marketing_start_date": "20110830"}, {"sample": false, "description": "1 CANISTER in 1 CARTON (45802-532-33)  / 100 g in 1 CANISTER", "package_ndc": "45802-532-33", "marketing_start_date": "20110830"}], "brand_name": "ketoconazole", "product_id": "45802-532_f9768109-216c-49f3-be2a-d0c3eac142b9", "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": "45802-532", "generic_name": "ketoconazole", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ketoconazole", "active_ingredients": [{"name": "KETOCONAZOLE", "strength": "2 g/100g"}], "application_number": "ANDA091550", "marketing_category": "ANDA", "marketing_start_date": "20110830", "listing_expiration_date": "20261231"}