FDA.reportPublic FDA data

Ketodan

Product NDC
43538-530
11-digit product format
435380530
Labeler code
43538
Product ID
43538-530_354d4926-b665-4e7e-a86a-5baae165a470
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketoconazole
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Medimetriks Pharmaceuticals, Inc.
Application
ANDA091550
Marketing category
ANDA
Marketing start
2012-06-15
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOCONAZOLE20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR9400W927I
Rxcui728550, 1300272

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
43538-530-10Ketodan100 g in 1 CANAEROSOL, FOAM1008
43538-530-10Ketodan1 in 1 CARTONAEROSOL, FOAM18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43538-530-10GM - Gram43538-530337a3162-6695-4d73-bf80-f35625b85c9212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ketoconazoleACTIVE INGREDIENTR9400W927IKETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
ketoconazoleACTIVE MOIETYR9400W927IKETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
alcoholINACTIVE INGREDIENT3K9958V90MKETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLKETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
brucine sulfateINACTIVE INGREDIENTKY7O12XPOQKETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
butaneINACTIVE INGREDIENT6LV4FOR43RKETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNKETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MKETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
potassium citrateINACTIVE INGREDIENTEE90ONI6FFKETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
propaneINACTIVE INGREDIENTT75W9911L6KETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3KETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YKETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
tert-butyl alcoholINACTIVE INGREDIENTMD83SFE959KETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RKETODAN (KETOCONAZOLE) AEROSOL, FOAM KETODAN (KETOCONAZOLE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43538-530KETODAN (KETOCONAZOLE) AEROSOL, FOAM [MEDIMETRIKS PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 2 package rows20241207_62f19bd8-926e-4e6b-9097-d81b894b95cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728550ketoconazole 2 % Topical FoamPSN62f19bd8-926e-4e6b-9097-d81b894b95cc8
1300272Ketodan 2 % Topical FoamPSN62f19bd8-926e-4e6b-9097-d81b894b95cc8
1300272ketoconazole 20 MG/ML Topical Foam [Ketodan]SBD62f19bd8-926e-4e6b-9097-d81b894b95cc8
728550ketoconazole 20 MG/ML Topical FoamSCD62f19bd8-926e-4e6b-9097-d81b894b95cc8
728550ketoconazole 2 % Topical FoamSY62f19bd8-926e-4e6b-9097-d81b894b95cc8
1300272Ketodan 2 % Topical FoamSY62f19bd8-926e-4e6b-9097-d81b894b95cc8
1300272Ketodan 20 MG/ML Topical FoamSY62f19bd8-926e-4e6b-9097-d81b894b95cc8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43538-530-10435380530101 CAN in 1 CARTON (43538-530-10) / 100 g in 1 CAN1 can2012-06-150000-00-00NoNoCurrent