ketoconazole

Generic: ketoconazole

Labeler: tolmar inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketoconazole
Generic Name ketoconazole
Labeler tolmar inc.
Dosage Form SHAMPOO, SUSPENSION
Routes
TOPICAL
Active Ingredients

ketoconazole 20 mg/mL

Manufacturer
TOLMAR Inc.

Identifiers & Regulatory

Product NDC 63646-010
Product ID 63646-010_eea5b1d8-7b6e-4783-afb5-3049efb9e5b1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076942
Listing Expiration 2026-12-31
Marketing Start 2005-04-11

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 63646010
Hyphenated Format 63646-010

Supplemental Identifiers

RxCUI
106336
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 ANDA076942 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE, PLASTIC (63646-010-04)
source: ndc

Packages (1)

63646-010-04 120 mL in 1 BOTTLE, PLASTIC (63646-010-04)

Ingredients (1)

ketoconazole (20 mg/mL)

Linked Drug Pages (1)

Ketoconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "eea5b1d8-7b6e-4783-afb5-3049efb9e5b1", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "unii": ["R9400W927I"], "rxcui": ["106336"], "spl_set_id": ["7036d1f2-c3f9-41d4-bc72-dd70e1691128"], "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": ["TOLMAR Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE, PLASTIC (63646-010-04)", "package_ndc": "63646-010-04", "marketing_start_date": "20050411"}], "brand_name": "Ketoconazole", "product_id": "63646-010_eea5b1d8-7b6e-4783-afb5-3049efb9e5b1", "dosage_form": "SHAMPOO, SUSPENSION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 3A5 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "63646-010", "generic_name": "Ketoconazole", "labeler_name": "TOLMAR Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketoconazole", "active_ingredients": [{"name": "KETOCONAZOLE", "strength": "20 mg/mL"}], "application_number": "ANDA076942", "marketing_category": "ANDA", "marketing_start_date": "20050411", "listing_expiration_date": "20261231"}