FDA.reportPublic FDA data

Fluconazole

Product NDC
65862-300
11-digit product format
658620300
Labeler code
65862
Product ID
65862-300_5305f9a9-119f-43e6-a48a-1598094d6c8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA079150
Marketing category
ANDA
Marketing start
2009-09-18
Substance
FLUCONAZOLE
Active strength
40 mg/mL
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
FLUCONAZOLE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui310352, 310353

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
65862-300-35Fluconazole1 in 1 CARTONPOWDER, FOR SUSPENSION126
65862-300-35Fluconazole35 mL in 1 BOTTLEPOWDER, FOR SUSPENSION3526

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-300-35ML - Milliliter65862-30026886d7b-3f96-4813-b1fe-8fe17815a42a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]12
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]12
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLFLUCONAZOLE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUCONAZOLE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]12
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUFLUCONAZOLE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]12
SUCROSEINACTIVE INGREDIENTC151H8M554FLUCONAZOLE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUCONAZOLE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]12
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KFLUCONAZOLE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]12
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEFLUCONAZOLE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-300FLUCONAZOLE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]26Current NDC, Legacy NDC, 2 package rows20240814_bf588f7e-89de-4b4e-8d33-c1ff2be1b34e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310352fluconazole 10 MG in 1 mL Oral SuspensionPSNbf588f7e-89de-4b4e-8d33-c1ff2be1b34e26
310353fluconazole 40 MG in 1 mL Oral SuspensionPSNbf588f7e-89de-4b4e-8d33-c1ff2be1b34e26
310352fluconazole 10 MG/ML Oral SuspensionSCDbf588f7e-89de-4b4e-8d33-c1ff2be1b34e26
310353fluconazole 40 MG/ML Oral SuspensionSCDbf588f7e-89de-4b4e-8d33-c1ff2be1b34e26
310352fluconazole 10 MG per 1 ML Oral SuspensionSYbf588f7e-89de-4b4e-8d33-c1ff2be1b34e26
310352fluconazole 10 MG per ML Powder for Oral SuspensionSYbf588f7e-89de-4b4e-8d33-c1ff2be1b34e26
310353fluconazole 1400 MG per 35 ML Oral SuspensionSYbf588f7e-89de-4b4e-8d33-c1ff2be1b34e26
310353fluconazole 200 MG per 5 ML Oral SuspensionSYbf588f7e-89de-4b4e-8d33-c1ff2be1b34e26
310352fluconazole 350 MG per 35 ML Powder for Oral SuspensionSYbf588f7e-89de-4b4e-8d33-c1ff2be1b34e26
310353fluconazole 40 MG per 1 ML Oral SuspensionSYbf588f7e-89de-4b4e-8d33-c1ff2be1b34e26
310353fluconazole 40 MG per ML Powder for Oral SuspensionSYbf588f7e-89de-4b4e-8d33-c1ff2be1b34e26
310352fluconazole 50 MG per 5 ML Powder for Oral SuspensionSYbf588f7e-89de-4b4e-8d33-c1ff2be1b34e26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-300-35658620300351 BOTTLE in 1 CARTON (65862-300-35) / 35 mL in 1 BOTTLE1 bottle2009-09-180000-00-00NoNoCurrent