FDA.reportPublic FDA data

Ketoconazole

Product NDC
50090-3288
11-digit product format
500903288
Labeler code
50090
Product ID
50090-3288_963fdd93-04a5-4f04-ae86-c96b5c4b9880
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoconazole
Dosage form
SHAMPOO, SUSPENSION
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA076942
Marketing category
ANDA
Marketing start
2005-04-11
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ketoconazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOCONAZOLE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR9400W927I
Rxcui106336

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
50090-3288-02023-11-30C16284748780-1f386c649-9de8-0266-e053-dadaa90a7c1aKetoconazole Shampoo
50090-3288-02023-01-30C16284748780-1f386c649-9de8-0266-e053-dadaa90a7c1aKetoconazole Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3288-0Ketoconazole118.28 mL in 1 BOTTLE, PLASTICSHAMPOO, SUSPENSION118.289

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3288-0ML - Milliliter50090-328808ad360e-4902-4478-849c-366ab1e582cb12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3288KETOCONAZOLE SHAMPOO, SUSPENSION [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 1 package rows20231130_c29d4ddc-aa1c-41c6-99ce-9aff35d213f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106336ketoconazole 2 % Medicated ShampooPSNc29d4ddc-aa1c-41c6-99ce-9aff35d213f69
106336ketoconazole 20 MG/ML Medicated ShampooSCDc29d4ddc-aa1c-41c6-99ce-9aff35d213f69
106336ketoconazole 2 % Medicated ShampooSYc29d4ddc-aa1c-41c6-99ce-9aff35d213f69

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3288-050090328800118.28 mL in 1 BOTTLE, PLASTIC (50090-3288-0) 118.28 ml2017-11-300000-00-00NoNoCurrent