FLUCONAZOLE

Product NDC
72189-342
11-digit product format
721890342
Labeler code
72189
Product ID
72189-342_2c4c6a02-d9b4-a905-e063-6394a90ae1ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUCONAZOLE
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA077253
Marketing category
ANDA
Marketing start
2022-03-31
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FLUCONAZOLE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUCONAZOLE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui197699

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
74f0b828-cb79-42cb-bb6c-81c9f5bd2648Product name220250623
fe6bb120-ebc6-6290-9eab-e842fdb6c841Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-342-01FLUCONAZOLE1 in 1 BOTTLETABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-342FLUCONAZOLE TABLET [DIRECT RX]2Current NDC, Legacy NDC, 1 package rows20250123_db886cfe-ea23-50c9-e053-2995a90a4d10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSNdb886cfe-ea23-50c9-e053-2995a90a4d102
197699fluconazole 150 MG Oral TabletSCDdb886cfe-ea23-50c9-e053-2995a90a4d102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-342-01721890342011 TABLET in 1 BOTTLE (72189-342-01) 1 tablet2022-03-310000-00-00NoNoCurrent