FDA.reportPublic FDA data

ketoconazole

Product NDC
72162-1417
11-digit product format
721621417
Labeler code
72162
Product ID
72162-1417_251364c4-cb46-490e-a6e4-bb95737322a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketoconazole
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA091550
Marketing category
ANDA
Marketing start
2011-08-30
Substance
KETOCONAZOLE
Active strength
2 g/100g
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
KETOCONAZOLE2 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR9400W927I
Rxcui728550

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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1417-1ketoconazole1 in 1 CARTONAEROSOL, FOAM1100
72162-1417-1ketoconazole100 g in 1 CANISTERAEROSOL, FOAM100100
72162-1417-2ketoconazole1 in 1 CARTONAEROSOL, FOAM1100
72162-1417-2ketoconazole50 g in 1 CANISTERAEROSOL, FOAM50100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1417-1GM - Gram72162-1417b2088642-2593-4cda-8bc2-66f1d721eca012025-02-10
72162-1417-2GM - Gram72162-1417dd072ff7-d256-4200-a195-6989effde26f12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1417KETOCONAZOLE AEROSOL, FOAM [BRYANT RANCH PREPACK]100Current NDC, 4 package rows20241228_ac98307e-315a-4fbd-81cb-cd936f2bfbae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728550ketoconazole 2 % Topical FoamPSNac98307e-315a-4fbd-81cb-cd936f2bfbae100
728550ketoconazole 20 MG/ML Topical FoamSCDac98307e-315a-4fbd-81cb-cd936f2bfbae100
728550ketoconazole 2 % Topical FoamSYac98307e-315a-4fbd-81cb-cd936f2bfbae100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1417-1721621417011 CANISTER in 1 CARTON (72162-1417-1) / 100 g in 1 CANISTER1 canister2024-12-24NoNoCurrent
72162-1417-2721621417021 CANISTER in 1 CARTON (72162-1417-2) / 50 g in 1 CANISTER1 canister2024-12-24NoNoCurrent