ketoconazole

Generic: ketoconazole

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketoconazole
Generic Name ketoconazole
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ketoconazole 200 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-4026
Product ID 51672-4026_3dd44662-95fb-0d34-e063-6294a90a5fbc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075319
Listing Expiration 2026-12-31
Marketing Start 1999-06-15

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 516724026
Hyphenated Format 51672-4026

Supplemental Identifiers

RxCUI
197853
UPC
0351672402662
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 ANDA075319 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BOX (51672-4026-0) / 10 TABLET in 1 BLISTER PACK
  • 100 TABLET in 1 BOTTLE (51672-4026-1)
  • 500 TABLET in 1 BOTTLE (51672-4026-2)
  • 30 TABLET in 1 BOTTLE (51672-4026-6)
  • 3 BLISTER PACK in 1 BOX (51672-4026-8) / 10 TABLET in 1 BLISTER PACK
  • 5 BLISTER PACK in 1 BOX (51672-4026-9) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (6)

51672-4026-0 10 BLISTER PACK in 1 BOX (51672-4026-0) / 10 TABLET in 1 BLISTER PACK 51672-4026-1 100 TABLET in 1 BOTTLE (51672-4026-1) 51672-4026-2 500 TABLET in 1 BOTTLE (51672-4026-2) 51672-4026-6 30 TABLET in 1 BOTTLE (51672-4026-6) 51672-4026-8 3 BLISTER PACK in 1 BOX (51672-4026-8) / 10 TABLET in 1 BLISTER PACK 51672-4026-9 5 BLISTER PACK in 1 BOX (51672-4026-9) / 10 TABLET in 1 BLISTER PACK

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": "3dd44662-95fb-0d34-e063-6294a90a5fbc", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "upc": ["0351672402662"], "unii": ["R9400W927I"], "rxcui": ["197853"], "spl_set_id": ["8ca815a8-bccb-4ee2-a042-922373329cae"], "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": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BOX (51672-4026-0)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "51672-4026-0", "marketing_start_date": "19990615"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (51672-4026-1)", "package_ndc": "51672-4026-1", "marketing_start_date": "19990615"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (51672-4026-2)", "package_ndc": "51672-4026-2", "marketing_start_date": "19990615"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (51672-4026-6)", "package_ndc": "51672-4026-6", "marketing_end_date": "20260831", "marketing_start_date": "19990615"}, {"sample": false, "description": "3 BLISTER PACK in 1 BOX (51672-4026-8)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "51672-4026-8", "marketing_start_date": "19990615"}, {"sample": false, "description": "5 BLISTER PACK in 1 BOX (51672-4026-9)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "51672-4026-9", "marketing_start_date": "19990615"}], "brand_name": "Ketoconazole", "product_id": "51672-4026_3dd44662-95fb-0d34-e063-6294a90a5fbc", "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": "51672-4026", "generic_name": "Ketoconazole", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "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": "19990615", "listing_expiration_date": "20261231"}