Fluconazole

Product NDC
71335-1448
11-digit product format
713351448
Labeler code
71335
Product ID
71335-1448_ef05e10f-f066-4d73-a4cc-fbd1790d2863
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076658
Marketing category
ANDA
Marketing start
2014-06-20
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1448-12024-05-20C16284748780-11030e365-1454-111a-e063-dadaa90a10e2Fluconazole Tablets USP
71335-1448-12024-01-30C16284748780-11030e365-1454-111a-e063-dadaa90a10e2Fluconazole Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1448-1Fluconazole1 in 1 DOSE PACKTABLET15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1448FLUCONAZOLE TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 1 package rows20241024_a499c43e-0454-4a8c-a547-31e9816babdd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSNa499c43e-0454-4a8c-a547-31e9816babdd5
197699fluconazole 150 MG Oral TabletSCDa499c43e-0454-4a8c-a547-31e9816babdd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1448-1713351448011 TABLET in 1 DOSE PACK (71335-1448-1) 1 tablet2014-06-200000-00-00NoNoCurrent