Home NDC 85384-0002 Tagrit Antifungal Treament Ketoconazole 1%
Product NDC 85384-0002
11-digit product format 853840002
Labeler code 85384
Product ID 85384-0002_a42bf040-8183-4a90-bf21-4596f5eacfc5
Type HUMAN OTC DRUG
Nonproprietary name Ketoconazole
Dosage form CREAM
Route TOPICAL
Labeler TAGRID LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-18
Substance KETOCONAZOLE
Active strength 10 mg/1000g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Tagrit Antifungal Treament Ketoconazole 1%
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength KETOCONAZOLE 10 mg/1000g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R9400W927I Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85384-0002-1 Tagrit Antifungal Treament Ketoconazole 1% 100 g in 1 TUBE CREAM 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85384-0002 TAGRIT ANTIFUNGAL TREAMENT KETOCONAZOLE 1% (KETOCONAZOLE) CREAM [TAGRID LLC] 1 Current NDC, 1 package rows 20250418_315a8832-c42f-c07a-e063-6394a90a8218.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 36 of 49 · 973 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85384-0002-1 85384000201 100 g in 1 TUBE (85384-0002-1) 100 g 2025-04-18 No No Current