Fluconazole

Product NDC
68071-2805
11-digit product format
680712805
Labeler code
68071
Product ID
68071-2805_e5beb9d7-978e-defd-e053-2995a90ac514
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077253
Marketing category
ANDA
Marketing start
2006-01-25
Marketing end
0000-00-00
Substance
FLUCONAZOLE
Active strength
200 mg/1
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 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
74f0b828-cb79-42cb-bb6c-81c9f5bd2648Product name220250623
fe6bb120-ebc6-6290-9eab-e842fdb6c841Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2805-22025-01-30C16284748780-12cef2736-90b2-d83d-e063-dadaa90ab31fFluconazole Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2805-2Fluconazole2 in 1 BOTTLETABLET21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2805FLUCONAZOLE TABLET [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20220810_e5beb9cd-aa39-2b37-e053-2995a90a8409.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197700fluconazole 200 MG Oral TabletPSNe5beb9cd-aa39-2b37-e053-2995a90a84091
197700fluconazole 200 MG Oral TabletSCDe5beb9cd-aa39-2b37-e053-2995a90a84091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2805-2680712805022 TABLET in 1 BOTTLE (68071-2805-2) 2 tablet2022-08-080000-00-00NoNoCurrent