FDA.reportPublic FDA data

Fluconazole

Product NDC
51655-435
11-digit product format
516550435
Labeler code
51655
Product ID
51655-435_49ed44bf-ddec-7235-e063-6394a90af996
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA077731
Marketing category
ANDA
Marketing start
2020-09-16
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluconazole
Listing expiration
2027-12-31

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
51655-435-862023-03-27C16284748780-1f386c649-cdd4-0266-e053-dadaa90a7c1aFluconazole Tablets USP Rx only
51655-435-862023-01-30C16284748780-1f386c649-cdd4-0266-e053-dadaa90a7c1aFluconazole Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-435-07Fluconazole7 in 1 BAGTABLET74
51655-435-86Fluconazole2 in 1 BAGTABLET24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-435FLUCONAZOLE TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 2 package rows20240723_c924c51c-ed7e-7e72-e053-2995a90adcd3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSNc924c51c-ed7e-7e72-e053-2995a90adcd34
197699fluconazole 150 MG Oral TabletSCDc924c51c-ed7e-7e72-e053-2995a90adcd34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-435-07516550435077 TABLET in 1 BAG (51655-435-07) 7 tablet2022-06-29NoNoCurrent
51655-435-86516550435862 TABLET in 1 BAG (51655-435-86) 2 tablet2020-09-160000-00-00NoNoCurrent