FDA.reportPublic FDA data

KETOCONAZOLE

Product NDC
61919-841
11-digit product format
619190841
Labeler code
61919
Product ID
61919-841_9c9765a3-204c-5fe5-e053-2a95a90ab030
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
KETOCONAZOLE
Dosage form
CREAM
Route
TOPICAL
Labeler
DIRECT RX
Application
ANDA076294
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
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
2021-12-31
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
61919-841-152023-01-30C16284748780-1f386c649-b91e-0266-e053-dadaa90a7c1aKETOCONAZOLE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-841-15KETOCONAZOLE15 g in 1 TUBECREAM153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-841-15GM - Gram61919-84179361e23-2a0b-4ae2-aa2b-ef2e5393162a12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOCONAZOLEACTIVE INGREDIENTR9400W927IKETOCONAZOLE CREAM [DIRECT RX]1
KETOCONAZOLEACTIVE MOIETYR9400W927IKETOCONAZOLE CREAM [DIRECT RX]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNKETOCONAZOLE CREAM [DIRECT RX]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSKETOCONAZOLE CREAM [DIRECT RX]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MKETOCONAZOLE CREAM [DIRECT RX]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HKETOCONAZOLE CREAM [DIRECT RX]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3KETOCONAZOLE CREAM [DIRECT RX]1
sodium sulfiteINACTIVE INGREDIENTVTK01UQK3GKETOCONAZOLE CREAM [DIRECT RX]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XKETOCONAZOLE CREAM [DIRECT RX]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YKETOCONAZOLE CREAM [DIRECT RX]1
waterINACTIVE INGREDIENT059QF0KO0RKETOCONAZOLE CREAM [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-841KETOCONAZOLE CREAM [DIRECT RX]3Legacy NDC, 1 package rows20200130_720927e8-7b3f-4ed9-9893-1be1ea122dc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
203088ketoconazole 2 % Topical CreamPSN720927e8-7b3f-4ed9-9893-1be1ea122dc83
203088ketoconazole 20 MG/ML Topical CreamSCD720927e8-7b3f-4ed9-9893-1be1ea122dc83
203088ketoconazole 2 % Topical CreamSY720927e8-7b3f-4ed9-9893-1be1ea122dc83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-841-156191908411515 g in 1 TUBE (61919-841-15) 15 g2014-01-010000-00-00NoNoCurrent