Fluconazole

Product NDC
68071-2906
11-digit product format
680712906
Labeler code
68071
Product ID
68071-2906_f06ec567-fcb0-2cf8-e053-2a95a90a9cc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077253
Marketing category
ANDA
Marketing start
2020-11-20
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 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
68071-2906-22025-01-30C16284748780-12cef2736-6019-d83d-e063-dadaa90ab31fFluconazole Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2906-2Fluconazole1 in 1 BLISTER PACKTABLET11
68071-2906-2Fluconazole1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2906FLUCONAZOLE TABLET [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 2 package rows20221223_f06e82bc-61d5-d07d-e053-2a95a90a23a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSNf06e82bc-61d5-d07d-e053-2a95a90a23a11
197699fluconazole 150 MG Oral TabletSCDf06e82bc-61d5-d07d-e053-2a95a90a23a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2906-2680712906021 BLISTER PACK in 1 CARTON (68071-2906-2) > 1 TABLET in 1 BLISTER PACK1 blister pack2022-12-220000-00-00NoNoCurrent