Ketoconazole

Product NDC
21695-556
11-digit product format
216950556
Labeler code
21695
Product ID
21695-556_836ebf14-fb11-45c3-9e0c-db1bebcd0f5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoconazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Rebel Distributors Corp
Application
ANDA075638
Marketing category
ANDA
Marketing start
2002-12-18
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
E
Listing certified through
2017-12-31
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
21695-556-602019-09-24C16284748780-1934fe258-4a7c-48b1-e053-8cdaa90a720aKetoconazole Cream, 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-556-60Ketoconazole1 in 1 CARTONCREAM11
21695-556-60Ketoconazole60 g in 1 TUBECREAM601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-556-60GM - Gram21695-5563e8b1fbd-7f8b-4354-8384-9b66d2f01c1812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KetoconazoleACTIVE INGREDIENTR9400W927IKETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
KetoconazoleACTIVE MOIETYR9400W927IKETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
Butylated HydroxyanisoleINACTIVE INGREDIENTREK4960K2UKETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNKETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSKETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MKETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HKETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XKETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YKETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
waterINACTIVE INGREDIENT059QF0KO0RKETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-556KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110121_836ebf14-fb11-45c3-9e0c-db1bebcd0f5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
203088ketoconazole 2 % Topical CreamPSN836ebf14-fb11-45c3-9e0c-db1bebcd0f5b1
203088ketoconazole 20 MG/ML Topical CreamSCD836ebf14-fb11-45c3-9e0c-db1bebcd0f5b1
203088ketoconazole 2 % Topical CreamSY836ebf14-fb11-45c3-9e0c-db1bebcd0f5b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-556-60216950556601 in 1 CARTONHistorical