Ketoconazole

Product NDC
68071-2902
11-digit product format
680712902
Labeler code
68071
Product ID
68071-2902_efbb79b8-9616-3ad9-e053-2a95a90afdc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoconazole
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA075319
Marketing category
ANDA
Marketing start
1999-06-15
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
68071-2902-32025-01-30C16284748780-12cef2736-5e13-d83d-e063-dadaa90ab31fKetoconazole Tablets USP, 200 MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2902-3Ketoconazole30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2902KETOCONAZOLE TABLET [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20221217_efbb79b0-5f43-7ada-e053-2995a90ae470.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197853ketoconazole 200 MG Oral TabletPSNefbb79b0-5f43-7ada-e053-2995a90ae4701
197853ketoconazole 200 MG Oral TabletSCDefbb79b0-5f43-7ada-e053-2995a90ae4701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2902-36807129020330 TABLET in 1 BOTTLE (68071-2902-3) 30 tablet2022-12-130000-00-00NoNoCurrent