fluconazole

Product NDC
50090-5299
11-digit product format
500905299
Labeler code
50090
Product ID
50090-5299_06f4b6eb-beb0-48ae-a320-de15f5740fd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208963
Marketing category
ANDA
Marketing start
2017-04-06
Substance
FLUCONAZOLE
Active strength
100 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
FLUCONAZOLE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui197698

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
50090-5299-02023-02-06C16284748780-1f386c649-c056-0266-e053-dadaa90a7c1aFluconazole Tablets, USP Rx only
50090-5299-02023-01-30C16284748780-1f386c649-c056-0266-e053-dadaa90a7c1aFluconazole Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5299-0fluconazole7 in 1 BOTTLETABLET73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5299FLUCONAZOLE TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 1 package rows20230208_08a54805-4fdf-48fd-bc3e-e9fa38f3c691.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSN08a54805-4fdf-48fd-bc3e-e9fa38f3c6913
197698fluconazole 100 MG Oral TabletSCD08a54805-4fdf-48fd-bc3e-e9fa38f3c6913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5299-0500905299007 TABLET in 1 BOTTLE (50090-5299-0) 7 tablet2020-10-270000-00-00NoNoCurrent