ketoconazole

Generic: ketoconazole

Labeler: esjay pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketoconazole
Generic Name ketoconazole
Labeler esjay pharma llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ketoconazole 200 mg/1

Manufacturer
Esjay Pharma LLC

Identifiers & Regulatory

Product NDC 70685-001
Product ID 70685-001_ba8ac2cf-fc6e-465e-84b9-518a041bfa5f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219129
Listing Expiration 2026-12-31
Marketing Start 2025-09-10

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 70685001
Hyphenated Format 70685-001

Supplemental Identifiers

RxCUI
197853
UPC
0370685001037 0370685001020 0370685001013
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 ANDA219129 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (70685-001-01)
  • 100 TABLET in 1 BOTTLE (70685-001-02)
  • 500 TABLET in 1 BOTTLE (70685-001-03)
source: ndc

Packages (3)

70685-001-01 30 TABLET in 1 BOTTLE (70685-001-01) 70685-001-02 100 TABLET in 1 BOTTLE (70685-001-02) 70685-001-03 500 TABLET in 1 BOTTLE (70685-001-03)

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": "ba8ac2cf-fc6e-465e-84b9-518a041bfa5f", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "upc": ["0370685001037", "0370685001020", "0370685001013"], "unii": ["R9400W927I"], "rxcui": ["197853"], "spl_set_id": ["9374da6b-2eb6-4ea9-bafc-2464a563f5f3"], "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": ["Esjay Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (70685-001-01)", "package_ndc": "70685-001-01", "marketing_start_date": "20250910"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (70685-001-02)", "package_ndc": "70685-001-02", "marketing_start_date": "20250910"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70685-001-03)", "package_ndc": "70685-001-03", "marketing_start_date": "20250910"}], "brand_name": "Ketoconazole", "product_id": "70685-001_ba8ac2cf-fc6e-465e-84b9-518a041bfa5f", "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": "70685-001", "generic_name": "Ketoconazole", "labeler_name": "Esjay Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketoconazole", "active_ingredients": [{"name": "KETOCONAZOLE", "strength": "200 mg/1"}], "application_number": "ANDA219129", "marketing_category": "ANDA", "marketing_start_date": "20250910", "listing_expiration_date": "20261231"}