Fluconazole

Product NDC
50090-6751
11-digit product format
500906751
Labeler code
50090
Product ID
50090-6751_9f34499a-080f-468e-b136-9e425ea07912
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077731
Marketing category
ANDA
Marketing start
2008-10-07
Substance
FLUCONAZOLE
Active strength
200 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
FLUCONAZOLE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui197700

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
50090-6751-0Fluconazole28 in 1 BOTTLETABLET285
50090-6751-1Fluconazole30 in 1 BOTTLETABLET305
50090-6751-3Fluconazole2 in 1 BOTTLETABLET25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6751FLUCONAZOLE TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, 3 package rows20231026_c6be26bb-af92-405b-9908-972d6e985cf0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197700fluconazole 200 MG Oral TabletPSNc6be26bb-af92-405b-9908-972d6e985cf05
197700fluconazole 200 MG Oral TabletSCDc6be26bb-af92-405b-9908-972d6e985cf05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6751-05009067510028 TABLET in 1 BOTTLE (50090-6751-0) 28 tablet2023-10-16NoNoCurrent
50090-6751-15009067510130 TABLET in 1 BOTTLE (50090-6751-1) 30 tablet2023-10-24NoNoCurrent
50090-6751-3500906751032 TABLET in 1 BOTTLE (50090-6751-3) 2 tablet2023-10-24NoNoCurrent