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 72189-180
Product ID 72189-180_2be953af-ba6e-e430-e063-6294a90a9a1a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075912
Listing Expiration 2026-12-31
Marketing Start 2021-02-24

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 72189180
Hyphenated Format 72189-180

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 ANDA075912 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 7 TABLET in 1 BOTTLE (72189-180-07)
source: ndc

Packages (1)

72189-180-07 7 TABLET in 1 BOTTLE (72189-180-07)

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": "2be953af-ba6e-e430-e063-6294a90a9a1a", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "unii": ["R9400W927I"], "rxcui": ["197853"], "spl_set_id": ["bc189ce2-3f10-260d-e053-2a95a90ae808"], "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 (72189-180-07)", "package_ndc": "72189-180-07", "marketing_start_date": "20210224"}], "brand_name": "KETOCONAZOLE", "product_id": "72189-180_2be953af-ba6e-e430-e063-6294a90a9a1a", "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": "72189-180", "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": "ANDA075912", "marketing_category": "ANDA", "marketing_start_date": "20210224", "listing_expiration_date": "20261231"}