Fluconazole

Product NDC
50090-6733
11-digit product format
500906733
Labeler code
50090
Product ID
50090-6733_daeded26-1306-4e0b-9137-ed7245ee23d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078423
Marketing category
ANDA
Marketing start
2021-04-22
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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6733-0Fluconazole7 in 1 BOTTLETABLET73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6733FLUCONAZOLE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20231016_a0f1c111-e11e-4b7e-b990-8bc271cbc940.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSNa0f1c111-e11e-4b7e-b990-8bc271cbc9403
197698fluconazole 100 MG Oral TabletSCDa0f1c111-e11e-4b7e-b990-8bc271cbc9403

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6733-0500906733007 TABLET in 1 BOTTLE (50090-6733-0) 7 tablet2023-10-06NoNoHistorical