ketoconazole

Generic: ketoconazole

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketoconazole
Generic Name ketoconazole
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ketoconazole 200 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-052
Product ID 72789-052_40311e8f-76f8-b6b1-e063-6394a90aa4c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210457
Listing Expiration 2026-12-31
Marketing Start 2018-06-26

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 72789052
Hyphenated Format 72789-052

Supplemental Identifiers

RxCUI
197853
UPC
0372789052304
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 ANDA210457 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (72789-052-30)
source: ndc

Packages (1)

72789-052-30 30 TABLET in 1 BOTTLE, PLASTIC (72789-052-30)

Ingredients (1)

ketoconazole (200 mg/1)

Linked Drug Pages (1)

KETOCONAZOLE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40311e8f-76f8-b6b1-e063-6394a90aa4c0", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "upc": ["0372789052304"], "unii": ["R9400W927I"], "rxcui": ["197853"], "spl_set_id": ["f162e616-21b4-49b1-b437-15e21001a6f0"], "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": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (72789-052-30)", "package_ndc": "72789-052-30", "marketing_start_date": "20221208"}], "brand_name": "KETOCONAZOLE", "product_id": "72789-052_40311e8f-76f8-b6b1-e063-6394a90aa4c0", "dosage_form": "TABLET", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 3A5 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "72789-052", "generic_name": "KETOCONAZOLE", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KETOCONAZOLE", "active_ingredients": [{"name": "KETOCONAZOLE", "strength": "200 mg/1"}], "application_number": "ANDA210457", "marketing_category": "ANDA", "marketing_start_date": "20180626", "listing_expiration_date": "20261231"}