FDA.reportPublic FDA data

Fluconazole

Product NDC
85766-104
11-digit product format
857660104
Labeler code
85766
Product ID
85766-104_5031f501-a03c-c192-e063-6294a90ae96c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA076658
Marketing category
ANDA
Marketing start
2014-06-20
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
Rxcui197698, 197699, 197700, 197701

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
85766-104-00Fluconazole10 in 1 DOSE PACKTABLET102
85766-104-00Fluconazole10 in 1 CARTONTABLET102
85766-104-01Fluconazole100 in 1 BOTTLETABLET1002
85766-104-05Fluconazole500 in 1 BOTTLETABLET5002
85766-104-10Fluconazole10 in 1 BOTTLETABLET102
85766-104-12Fluconazole12 in 1 BOTTLETABLET122
85766-104-20Fluconazole20 in 1 BOTTLETABLET202
85766-104-30Fluconazole30 in 1 BOTTLETABLET302
85766-104-60Fluconazole60 in 1 BOTTLETABLET602
85766-104-90Fluconazole90 in 1 BOTTLETABLET902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSN8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2
197699fluconazole 150 MG Oral TabletPSN8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2
197700fluconazole 200 MG Oral TabletPSN8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2
197701fluconazole 50 MG Oral TabletPSN8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2
197698fluconazole 100 MG Oral TabletSCD8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2
197699fluconazole 150 MG Oral TabletSCD8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2
197700fluconazole 200 MG Oral TabletSCD8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2
197701fluconazole 50 MG Oral TabletSCD8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-104-008576601040010 DOSE PACK in 1 CARTON (85766-104-00) / 10 TABLET in 1 DOSE PACK10 dose pack2025-10-10NoNoHistorical
85766-104-0185766010401100 TABLET in 1 BOTTLE (85766-104-01) 100 tablet2025-10-10NoNoHistorical
85766-104-0585766010405500 TABLET in 1 BOTTLE (85766-104-05) 500 tablet2025-10-10NoNoHistorical
85766-104-108576601041010 TABLET in 1 BOTTLE (85766-104-10) 10 tablet2025-10-10NoNoHistorical
85766-104-128576601041212 TABLET in 1 BOTTLE (85766-104-12) 12 tablet2025-10-10NoNoHistorical
85766-104-208576601042020 TABLET in 1 BOTTLE (85766-104-20) 20 tablet2025-10-10NoNoHistorical
85766-104-308576601043030 TABLET in 1 BOTTLE (85766-104-30) 30 tablet2025-10-10NoNoHistorical
85766-104-608576601046060 TABLET in 1 BOTTLE (85766-104-60) 60 tablet2025-10-10NoNoHistorical
85766-104-908576601049090 TABLET in 1 BOTTLE (85766-104-90) 90 tablet2025-10-10NoNoHistorical