ketoconazole

Generic: ketoconazole

Labeler: burel pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketoconazole
Generic Name ketoconazole
Labeler burel pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ketoconazole 200 mg/1

Manufacturer
Burel Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 35573-433
Product ID 35573-433_748e48d8-09d3-413c-b724-883b6b47f01e
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 35573433
Hyphenated Format 35573-433

Supplemental Identifiers

RxCUI
197853
UPC
0335573433307
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 ANDA075912 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (35573-433-02)
  • 30 TABLET in 1 BOTTLE (35573-433-30)
source: ndc

Packages (2)

35573-433-02 100 TABLET in 1 BOTTLE (35573-433-02) 35573-433-30 30 TABLET in 1 BOTTLE (35573-433-30)

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": "748e48d8-09d3-413c-b724-883b6b47f01e", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "upc": ["0335573433307"], "unii": ["R9400W927I"], "rxcui": ["197853"], "spl_set_id": ["57e81e13-b395-4dbd-b660-3038de41a838"], "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": ["Burel Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (35573-433-02)", "package_ndc": "35573-433-02", "marketing_start_date": "20200410"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (35573-433-30)", "package_ndc": "35573-433-30", "marketing_start_date": "20200410"}], "brand_name": "KETOCONAZOLE", "product_id": "35573-433_748e48d8-09d3-413c-b724-883b6b47f01e", "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": "35573-433", "generic_name": "ketoconazole", "labeler_name": "Burel Pharmaceuticals, LLC", "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"}