FDA.reportPublic FDA data

ketoconazole

Product NDC
63629-8676
11-digit product format
636298676
Labeler code
63629
Product ID
63629-8676_8443f3a1-8b03-4f97-9759-e1b925b3ae37
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
63629-8676-1ketoconazole1 in 1 CARTONAEROSOL, FOAM1105
63629-8676-1ketoconazole50 g in 1 CANISTERAEROSOL, FOAM50105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8676-1GM - Gram63629-8676ecbe7dae-aaff-41b1-bdd4-369bdd6f410912023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8676KETOCONAZOLE AEROSOL, FOAM [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 2 package rows20241024_513370d5-2e9f-4677-a0f2-63ff76142909.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728550ketoconazole 2 % Topical FoamPSN513370d5-2e9f-4677-a0f2-63ff76142909105
728550ketoconazole 20 MG/ML Topical FoamSCD513370d5-2e9f-4677-a0f2-63ff76142909105
728550ketoconazole 2 % Topical FoamSY513370d5-2e9f-4677-a0f2-63ff76142909105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8676-1636298676011 CANISTER in 1 CARTON (63629-8676-1) / 50 g in 1 CANISTER1 canister2011-08-300000-00-00NoNoCurrent