1% ketoconazole

Generic: ketoconazole

Labeler: tagrid llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name 1% ketoconazole
Generic Name ketoconazole
Labeler tagrid llc
Dosage Form SHAMPOO
Routes
TOPICAL
Active Ingredients

ketoconazole 10 mg/mL

Manufacturer
TAGRID LLC

Identifiers & Regulatory

Product NDC 85384-0001
Product ID 85384-0001_30b75584-3a1f-c125-e063-6294a90acaa7
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2025-03-31

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 853840001
Hyphenated Format 85384-0001

Supplemental Identifiers

RxCUI
240812
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 1% ketoconazole (source: ndc)
Generic Name ketoconazole (source: ndc)
Application Number M005 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 250 mL in 1 BOTTLE (85384-0001-1)
source: ndc

Packages (1)

85384-0001-1 250 mL in 1 BOTTLE (85384-0001-1)

Ingredients (1)

ketoconazole (10 mg/mL)

Linked Drug Pages (1)

1% ketoconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "30b75584-3a1f-c125-e063-6294a90acaa7", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "unii": ["R9400W927I"], "rxcui": ["240812"], "spl_set_id": ["30b75584-3a1e-c125-e063-6294a90acaa7"], "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": ["TAGRID LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "250 mL in 1 BOTTLE (85384-0001-1)", "package_ndc": "85384-0001-1", "marketing_start_date": "20250331"}], "brand_name": "1% ketoconazole", "product_id": "85384-0001_30b75584-3a1f-c125-e063-6294a90acaa7", "dosage_form": "SHAMPOO", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 3A5 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "85384-0001", "generic_name": "Ketoconazole", "labeler_name": "TAGRID LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "1% ketoconazole", "active_ingredients": [{"name": "KETOCONAZOLE", "strength": "10 mg/mL"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250331", "listing_expiration_date": "20261231"}