Fluconazole

Product NDC
50436-0103
11-digit product format
504360103
Labeler code
50436
Product ID
50436-0103_e1a365a3-5367-4d01-8728-3c4c1a43a2e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA077253
Marketing category
ANDA
Marketing start
2006-01-25
Marketing end
0000-00-00
Substance
FLUCONAZOLE
Active strength
150 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
No
Listing certified through
2020-12-31
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
50436-0103-12021-01-29C16284748780-1ba0f9c33-2d42-a910-e053-dadaa90a0b85Fluconazole Tablets, for oral use rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0103-1Fluconazole1 in 1 BLISTER PACKTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0103FLUCONAZOLE TABLET [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20180523_588a179b-646b-4955-ae55-6096760e5f7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSN588a179b-646b-4955-ae55-6096760e5f7d2
197699fluconazole 150 MG Oral TabletSCD588a179b-646b-4955-ae55-6096760e5f7d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0103-1504360103011 in 1 BLISTER PACKHistorical