Fluconazole

Product NDC
69189-5016
11-digit product format
691895016
Labeler code
69189
Product ID
69189-5016_addc5593-3e50-4600-914e-9ba6e12d0592
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Avera McKennan Hospital
Application
NDA019949
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-02-04
Marketing end
0000-00-00
Substance
FLUCONAZOLE
Active strength
100 mg/1
Pharmacologic classes
Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
74f0b828-cb79-42cb-bb6c-81c9f5bd2648Product name220250623
fe6bb120-ebc6-6290-9eab-e842fdb6c841Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69189-5016-12020-01-31C16284748780-19d75b9cf-da93-f424-e053-dadaa90a57ceFLUCONAZOLE Fluconazole Tablets Fluconazole for Oral Suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69189-5016-1Fluconazole1 in 1 DOSE PACKTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69189-5016FLUCONAZOLE TABLET [AVERA MCKENNAN HOSPITAL]1Legacy NDC, 1 package rows20170412_6d98f8e4-d358-4edf-b9e5-9fbd85141641.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSN6d98f8e4-d358-4edf-b9e5-9fbd851416411
197698fluconazole 100 MG Oral TabletSCD6d98f8e4-d358-4edf-b9e5-9fbd851416411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69189-5016-1691895016011 in 1 DOSE PACKHistorical