Fluconazole

Product NDC
50090-3899
11-digit product format
500903899
Labeler code
50090
Product ID
50090-3899_ba2d176f-978d-46bf-8076-3ebdb8e4c3d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078423
Marketing category
ANDA
Marketing start
2017-02-24
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
50090-3899-02023-01-30C16284748780-1f386c649-ea3b-0266-e053-dadaa90a7c1aFluconazole Tablets, USP
50090-3899-22023-01-30C16284748780-1f386c649-ea3b-0266-e053-dadaa90a7c1aFluconazole Tablets, USP
50090-3899-32023-01-30C16284748780-1f386c649-ea3b-0266-e053-dadaa90a7c1aFluconazole Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3899-0Fluconazole1 in 1 BLISTER PACKTABLET15
50090-3899-0Fluconazole1 in 1 CARTONTABLET15
50090-3899-2Fluconazole2 in 1 BOTTLE, PLASTICTABLET25
50090-3899-3Fluconazole4 in 1 BOTTLE, PLASTICTABLET45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3899FLUCONAZOLE TABLET [A-S MEDICATION SOLUTIONS]5Legacy NDC, 4 package rows20190501_4997945f-5d19-4128-8c40-73ffc4cd16c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSN4997945f-5d19-4128-8c40-73ffc4cd16c65
197699fluconazole 150 MG Oral TabletSCD4997945f-5d19-4128-8c40-73ffc4cd16c65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3899-0500903899001 BLISTER PACK in 1 CARTON (50090-3899-0) > 1 TABLET in 1 BLISTER PACK1 blister pack2018-12-040000-00-00NoNoCurrent
50090-3899-2500903899022 TABLET in 1 BOTTLE, PLASTIC (50090-3899-2) 2 tablet2017-02-240000-00-00NoNoCurrent
50090-3899-3500903899034 TABLET in 1 BOTTLE, PLASTIC (50090-3899-3) 4 tablet2017-02-240000-00-00NoNoCurrent