FDA.reportPublic FDA data

Fluconazole

Product NDC
53002-4198
11-digit product format
530024198
Labeler code
53002
Product ID
53002-4198_1bdbf3b8-3e0c-4d92-bcfc-2aa8010ab656
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
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
2021-12-31
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
53002-4198-12023-01-30C16284748780-1f386c649-dc7e-0266-e053-dadaa90a7c1aFluconazole Tablets
53002-4198-22023-01-30C16284748780-1f386c649-dc7e-0266-e053-dadaa90a7c1aFluconazole Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-4198-1Fluconazole12 in 1 CARTONTABLET121
53002-4198-1Fluconazole1 in 1 BLISTER PACKTABLET11
53002-4198-2Fluconazole12 in 1 CARTONTABLET121
53002-4198-2Fluconazole1 in 1 BLISTER PACKTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-4198FLUCONAZOLE TABLET [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 4 package rows20201222_ae776a0d-b30b-4a41-b186-e2d3feee61c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSNae776a0d-b30b-4a41-b186-e2d3feee61c11
197699fluconazole 150 MG Oral TabletSCDae776a0d-b30b-4a41-b186-e2d3feee61c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-4198-15300241980112 BLISTER PACK in 1 CARTON (53002-4198-1) > 1 TABLET in 1 BLISTER PACK12 blister pack2020-01-010000-00-00NoNoCurrent
53002-4198-25300241980212 BLISTER PACK in 1 CARTON (53002-4198-2) > 1 TABLET in 1 BLISTER PACK12 blister pack2020-01-010000-00-00NoNoCurrent