KETOCONAZOLE

Product NDC
66267-400
11-digit product format
662670400
Labeler code
66267
Product ID
66267-400_da727156-1daf-5694-e053-2a95a90acbd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
KETOCONAZOLE
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA210457
Marketing category
ANDA
Marketing start
2018-06-26
Marketing end
0000-00-00
Substance
KETOCONAZOLE
Active strength
200 mg/1
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
2023-12-31
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
66267-400-202025-01-30C16284748780-12cef2736-7080-d83d-e063-dadaa90ab31fKetoconazole Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-400-20KETOCONAZOLE20 in 1 BOTTLETABLET203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-400KETOCONAZOLE TABLET [NUCARE PHARMACEUTICALS,INC.]3Legacy NDC, 1 package rows20220318_aae6c08a-8610-b833-e053-2a95a90a3e6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197853ketoconazole 200 MG Oral TabletPSNaae6c08a-8610-b833-e053-2a95a90a3e6b3
197853ketoconazole 200 MG Oral TabletSCDaae6c08a-8610-b833-e053-2a95a90a3e6b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-400-206626704002020 TABLET in 1 BOTTLE (66267-400-20) 20 tablet2020-07-200000-00-00NoNoCurrent