ketoconazole

Generic: ketoconazole

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketoconazole
Generic Name ketoconazole
Labeler a-s medication solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ketoconazole 200 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6142
Product ID 50090-6142_53e92009-965c-4487-9143-6ca9159893d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075912
Listing Expiration 2026-12-31
Marketing Start 2020-04-10

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 500906142
Hyphenated Format 50090-6142

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 (50090-6142-1)
source: ndc

Packages (1)

50090-6142-1 7 TABLET in 1 BOTTLE (50090-6142-1)

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": "53e92009-965c-4487-9143-6ca9159893d6", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "unii": ["R9400W927I"], "rxcui": ["197853"], "spl_set_id": ["517c29fc-2a2a-4bd5-a8bb-b464a65d2be0"], "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": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "7 TABLET in 1 BOTTLE (50090-6142-1)", "package_ndc": "50090-6142-1", "marketing_start_date": "20221003"}], "brand_name": "KETOCONAZOLE", "product_id": "50090-6142_53e92009-965c-4487-9143-6ca9159893d6", "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": "50090-6142", "generic_name": "ketoconazole", "labeler_name": "A-S Medication Solutions", "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": "20200410", "listing_expiration_date": "20261231"}