FDA.reportPublic FDA data

Ketoconazole

Product NDC
53217-015
11-digit product format
532170015
Labeler code
53217
Product ID
53217-015_60077487-aec7-4042-99ec-6f531bb31fdf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoconazole
Dosage form
SHAMPOO, SUSPENSION
Route
TOPICAL
Labeler
Aidarex Pharmaceuticals LLC
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
2019-12-31
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
53217-015-012020-01-31C16284748780-19d75b9d0-7657-f424-e053-dadaa90a57ceKetoconazole Shampoo, 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-015-01Ketoconazole120 mL in 1 BOTTLE, PLASTICSHAMPOO, SUSPENSION1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-015-01ML - Milliliter53217-01501184ce0-b8dd-4a85-8e66-c4022bff640f12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOCONAZOLEACTIVE INGREDIENTR9400W927IKETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
KETOCONAZOLEACTIVE MOIETYR9400W927IKETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972DKETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
DISODIUM LAURETH SULFOSUCCINATEINACTIVE INGREDIENTD6DH1DTN7EKETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAKETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBKETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
IMIDUREAINACTIVE INGREDIENTM629807ATLKETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
PEG-120 METHYL GLUCOSE DIOLEATEINACTIVE INGREDIENTYM0K64F20VKETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XKETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IKETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RKETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-015KETOCONAZOLE SHAMPOO, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140214_dfac6776-1151-4d01-a099-9de11c9dc7fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106336ketoconazole 2 % Medicated ShampooPSNdfac6776-1151-4d01-a099-9de11c9dc7fa1
106336ketoconazole 20 MG/ML Medicated ShampooSCDdfac6776-1151-4d01-a099-9de11c9dc7fa1
106336ketoconazole 2 % Medicated ShampooSYdfac6776-1151-4d01-a099-9de11c9dc7fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53217-015-0153217001501120 mL in 1 BOTTLE, PLASTIC120 mlHistorical