Ketoconazole

Product NDC
50090-1220
11-digit product format
500901220
Labeler code
50090
Product ID
50090-1220_872126b2-e2bb-4a0f-aa98-d7c143fb5d0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoconazole
Dosage form
SHAMPOO, SUSPENSION
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA076419
Marketing category
ANDA
Marketing start
2010-01-19
Marketing end
0000-00-00
Substance
KETOCONAZOLE
Active strength
20 mg/mL
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
50090-1220-02023-01-30C16284748780-1f386c649-ab4b-0266-e053-dadaa90a7c1aKetoconazole Shampoo, 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1220-0Ketoconazole120 mL in 1 BOTTLESHAMPOO, SUSPENSION12010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1220-0ML - Milliliter50090-12205bbecd7c-10c2-4835-9054-ebed1b7441d412018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1220KETOCONAZOLE SHAMPOO, SUSPENSION [A-S MEDICATION SOLUTIONS]10Legacy NDC, 1 package rows20210223_2c5e02ba-c165-4ffb-bd05-fbd4243725b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106336ketoconazole 2 % Medicated ShampooPSN2c5e02ba-c165-4ffb-bd05-fbd4243725b710
106336ketoconazole 20 MG/ML Medicated ShampooSCD2c5e02ba-c165-4ffb-bd05-fbd4243725b710
106336ketoconazole 2 % Medicated ShampooSY2c5e02ba-c165-4ffb-bd05-fbd4243725b710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1220-050090122000120 mL in 1 BOTTLE (50090-1220-0) 120 ml2014-11-280000-00-00NoNoCurrent