ketoconazole

Generic: ketoconazole

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketoconazole
Generic Name ketoconazole
Labeler direct_rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ketoconazole 200 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-428
Product ID 72189-428_2c4d6606-d6a7-0085-e063-6294a90acaa2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075319
Listing Expiration 2026-12-31
Marketing Start 2023-03-01

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 72189428
Hyphenated Format 72189-428

Supplemental Identifiers

RxCUI
197853
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 ANDA075319 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 7 TABLET in 1 BOTTLE (72189-428-07)
source: ndc

Packages (1)

72189-428-07 7 TABLET in 1 BOTTLE (72189-428-07)

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": "2c4d6606-d6a7-0085-e063-6294a90acaa2", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "unii": ["R9400W927I"], "rxcui": ["197853"], "spl_set_id": ["f5dc1e67-639f-5476-e053-2995a90a4210"], "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": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "7 TABLET in 1 BOTTLE (72189-428-07)", "package_ndc": "72189-428-07", "marketing_start_date": "20230301"}], "brand_name": "Ketoconazole", "product_id": "72189-428_2c4d6606-d6a7-0085-e063-6294a90acaa2", "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": "72189-428", "generic_name": "Ketoconazole", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketoconazole", "active_ingredients": [{"name": "KETOCONAZOLE", "strength": "200 mg/1"}], "application_number": "ANDA075319", "marketing_category": "ANDA", "marketing_start_date": "20230301", "listing_expiration_date": "20261231"}