FDA.reportPublic FDA data

Diflucan

Product NDC
0049-3450
11-digit product format
000493450
Labeler code
0049
Product ID
0049-3450_c835d7dd-af65-4b2c-a92c-42d1986f902d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluconazole
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Roerig
Application
NDA020090
Marketing category
NDA
Marketing start
1993-12-23
Substance
FLUCONAZOLE
Active strength
1400 mg/35mL
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
Diflucan
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUCONAZOLE1400 mg/35mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui197698, 197699, 197700, 197701, 201900, 201901, 207106, 207107, 207108, 207112, 310352, 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
0049-3450-19Diflucan35 mL in 1 BOTTLEPOWDER, FOR SUSPENSION3557
0049-3450-19Diflucan1 in 1 CARTONPOWDER, FOR SUSPENSION157

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0049-3450-19ML - Milliliter0049-34509b900856-23c8-4b2a-9ea9-a66838de0fb412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYDIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]22
FLUCONAZOLEACTIVE MOIETY8VZV102JFYDIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]22
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]22
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]22
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JDIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]22
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]22
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]22
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]22
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]22
POVIDONESINACTIVE INGREDIENTFZ989GH94EDIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]22
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]22
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]22
SUCROSEINACTIVE INGREDIENTC151H8M554DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]22
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]22
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KDIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]22
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0049-3450DIFLUCAN (FLUCONAZOLE) TABLET DIFLUCAN (FLUCONAZOLE) POWDER, FOR SUSPENSION [ROERIG]54Current NDC, Legacy NDC, 2 package rows20250328_f694c617-3383-416c-91b6-b94fda371204.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
201900Diflucan 10 MG in 1 mL Oral SuspensionPSNf694c617-3383-416c-91b6-b94fda37120457
207107DIFLUCAN 100 MG Oral TabletPSNf694c617-3383-416c-91b6-b94fda37120457
207108Diflucan 150 MG Oral TabletPSNf694c617-3383-416c-91b6-b94fda37120457
207112Diflucan 200 MG Oral TabletPSNf694c617-3383-416c-91b6-b94fda37120457
201901Diflucan 40 MG in 1 mL Oral SuspensionPSNf694c617-3383-416c-91b6-b94fda37120457
207106DIFLUCAN 50 MG Oral TabletPSNf694c617-3383-416c-91b6-b94fda37120457
310352fluconazole 10 MG in 1 mL Oral SuspensionPSNf694c617-3383-416c-91b6-b94fda37120457
197698fluconazole 100 MG Oral TabletPSNf694c617-3383-416c-91b6-b94fda37120457
197699fluconazole 150 MG Oral TabletPSNf694c617-3383-416c-91b6-b94fda37120457
197700fluconazole 200 MG Oral TabletPSNf694c617-3383-416c-91b6-b94fda37120457
310353fluconazole 40 MG in 1 mL Oral SuspensionPSNf694c617-3383-416c-91b6-b94fda37120457
197701fluconazole 50 MG Oral TabletPSNf694c617-3383-416c-91b6-b94fda37120457
201900fluconazole 10 MG/ML Oral Suspension [Diflucan]SBDf694c617-3383-416c-91b6-b94fda37120457
207107fluconazole 100 MG Oral Tablet [Diflucan]SBDf694c617-3383-416c-91b6-b94fda37120457
207108fluconazole 150 MG Oral Tablet [Diflucan]SBDf694c617-3383-416c-91b6-b94fda37120457
207112fluconazole 200 MG Oral Tablet [Diflucan]SBDf694c617-3383-416c-91b6-b94fda37120457
201901fluconazole 40 MG/ML Oral Suspension [Diflucan]SBDf694c617-3383-416c-91b6-b94fda37120457
207106fluconazole 50 MG Oral Tablet [Diflucan]SBDf694c617-3383-416c-91b6-b94fda37120457
310352fluconazole 10 MG/ML Oral SuspensionSCDf694c617-3383-416c-91b6-b94fda37120457
197698fluconazole 100 MG Oral TabletSCDf694c617-3383-416c-91b6-b94fda37120457
197699fluconazole 150 MG Oral TabletSCDf694c617-3383-416c-91b6-b94fda37120457
197700fluconazole 200 MG Oral TabletSCDf694c617-3383-416c-91b6-b94fda37120457
310353fluconazole 40 MG/ML Oral SuspensionSCDf694c617-3383-416c-91b6-b94fda37120457
197701fluconazole 50 MG Oral TabletSCDf694c617-3383-416c-91b6-b94fda37120457
201900Diflucan 10 MG per 1 ML Oral SuspensionSYf694c617-3383-416c-91b6-b94fda37120457
207107Diflucan 100 MG Oral TabletSYf694c617-3383-416c-91b6-b94fda37120457
201901Diflucan 1400 MG per 35 ML Oral SuspensionSYf694c617-3383-416c-91b6-b94fda37120457
207108Diflucan 150 MG Oral TabletSYf694c617-3383-416c-91b6-b94fda37120457
207112Diflucan 200 MG Oral TabletSYf694c617-3383-416c-91b6-b94fda37120457
201901Diflucan 200 MG per 5 ML Oral SuspensionSYf694c617-3383-416c-91b6-b94fda37120457
201900Diflucan 350 MG per 35 ML Oral SuspensionSYf694c617-3383-416c-91b6-b94fda37120457
201901Diflucan 40 MG per 1 ML Oral SuspensionSYf694c617-3383-416c-91b6-b94fda37120457
207106Diflucan 50 MG Oral TabletSYf694c617-3383-416c-91b6-b94fda37120457
201900Diflucan 50 MG per 5 ML Oral SuspensionSYf694c617-3383-416c-91b6-b94fda37120457
310352fluconazole 10 MG per 1 ML Oral SuspensionSYf694c617-3383-416c-91b6-b94fda37120457
310352fluconazole 10 MG per ML Powder for Oral SuspensionSYf694c617-3383-416c-91b6-b94fda37120457
310353fluconazole 1400 MG per 35 ML Oral SuspensionSYf694c617-3383-416c-91b6-b94fda37120457
310353fluconazole 200 MG per 5 ML Oral SuspensionSYf694c617-3383-416c-91b6-b94fda37120457
310352fluconazole 350 MG per 35 ML Powder for Oral SuspensionSYf694c617-3383-416c-91b6-b94fda37120457
310353fluconazole 40 MG per 1 ML Oral SuspensionSYf694c617-3383-416c-91b6-b94fda37120457
310353fluconazole 40 MG per ML Powder for Oral SuspensionSYf694c617-3383-416c-91b6-b94fda37120457
310352fluconazole 50 MG per 5 ML Powder for Oral SuspensionSYf694c617-3383-416c-91b6-b94fda37120457

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0049-3450-19000493450191 BOTTLE in 1 CARTON (0049-3450-19) / 35 mL in 1 BOTTLE1 bottle1993-12-230000-00-00NoNoCurrent