FDA.reportPublic FDA data

Fluconazole

Product NDC
68788-8526
11-digit product format
687888526
Labeler code
68788
Product ID
68788-8526_b6d6f745-a593-40dd-9782-4783ed72e85f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077731
Marketing category
ANDA
Marketing start
2023-09-20
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
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
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
68788-8526-0Fluconazole1 in 1 BOTTLETABLET14
68788-8526-1Fluconazole10 in 1 BOTTLETABLET104
68788-8526-2Fluconazole20 in 1 BOTTLETABLET204
68788-8526-3Fluconazole30 in 1 BOTTLETABLET304
68788-8526-6Fluconazole60 in 1 BOTTLETABLET604
68788-8526-8Fluconazole2 in 1 BOTTLETABLET24
68788-8526-9Fluconazole90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8526FLUCONAZOLE TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 7 package rows20250515_eeeb82e1-d668-418e-9716-f8bcf72f80c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197700fluconazole 200 MG Oral TabletPSNeeeb82e1-d668-418e-9716-f8bcf72f80c04
197700fluconazole 200 MG Oral TabletSCDeeeb82e1-d668-418e-9716-f8bcf72f80c04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8526-0687888526001 TABLET in 1 BOTTLE (68788-8526-0) 1 tablet2023-09-20NoNoHistorical
68788-8526-16878885260110 TABLET in 1 BOTTLE (68788-8526-1) 10 tablet2023-09-20NoNoHistorical
68788-8526-26878885260220 TABLET in 1 BOTTLE (68788-8526-2) 20 tablet2023-09-20NoNoHistorical
68788-8526-36878885260330 TABLET in 1 BOTTLE (68788-8526-3) 30 tablet2023-09-20NoNoHistorical
68788-8526-66878885260660 TABLET in 1 BOTTLE (68788-8526-6) 60 tablet2023-09-20NoNoHistorical
68788-8526-8687888526082 TABLET in 1 BOTTLE (68788-8526-8) 2 tablet2023-09-20NoNoHistorical
68788-8526-96878885260990 TABLET in 1 BOTTLE (68788-8526-9) 90 tablet2023-09-20NoNoHistorical