Ketoconazole

Product NDC
50090-1524
11-digit product format
500901524
Labeler code
50090
Product ID
50090-1524_a73d54e9-ef4e-4a6c-9b4b-914fb78e1a20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoconazole
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA075638
Marketing category
ANDA
Marketing start
2002-12-18
Marketing end
0000-00-00
Substance
KETOCONAZOLE
Active strength
20 mg/g
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1524-02023-01-30C16284748780-1f386c649-9a59-0266-e053-dadaa90a7c1aKetoconazole Cream, 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1524-0Ketoconazole15 g in 1 TUBECREAM1511
50090-1524-0Ketoconazole1 in 1 CARTONCREAM111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1524-0GM - Gram50090-15242c61f200-a20f-4a46-a00d-2a92650564e812018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1524KETOCONAZOLE CREAM [A-S MEDICATION SOLUTIONS]11Legacy NDC, 2 package rows20210616_2b3bdb6e-2b48-4979-ae08-bd17cd74130e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
203088ketoconazole 2 % Topical CreamPSN2b3bdb6e-2b48-4979-ae08-bd17cd74130e11
203088ketoconazole 20 MG/ML Topical CreamSCD2b3bdb6e-2b48-4979-ae08-bd17cd74130e11
203088ketoconazole 2 % Topical CreamSY2b3bdb6e-2b48-4979-ae08-bd17cd74130e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1524-0500901524001 TUBE in 1 CARTON (50090-1524-0) > 15 g in 1 TUBE1 tube2014-12-110000-00-00NoNoCurrent