FDA.reportPublic FDA data

Fluconazole

Product NDC
59762-5029
11-digit product format
597625029
Labeler code
59762
Product ID
59762-5029_5a926244-1653-4a4e-9a60-9713a91d2485
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluconazole
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA020090
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1993-12-23
Substance
FLUCONAZOLE
Active strength
10 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
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
FLUCONAZOLE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui197698, 197699, 197700, 197701, 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
59762-5029-1Fluconazole1 in 1 CARTONPOWDER, FOR SUSPENSION143
59762-5029-1Fluconazole35 mL in 1 BOTTLEPOWDER, FOR SUSPENSION3543

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-5029-1ML - Milliliter59762-502967c6a53e-1afa-4248-a9db-cada247f5ca712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]17
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]17
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]17
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLFLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]17
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JFLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]17
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]17
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]17
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]17
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]17
POVIDONESINACTIVE INGREDIENTFZ989GH94EFLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]17
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]17
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUFLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]17
SUCROSEINACTIVE INGREDIENTC151H8M554FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]17
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]17
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KFLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]17
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEFLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [GREENSTONE LLC]17
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]13
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]13
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]13
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLFLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]13
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JFLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]13
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]13
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]13
POVIDONESINACTIVE INGREDIENTFZ989GH94EFLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]13
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]13
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUFLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]13
SUCROSEINACTIVE INGREDIENTC151H8M554FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]13
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KFLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]13
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEFLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-5029FLUCONAZOLE TABLET FLUCONAZOLE POWDER, FOR SUSPENSION [MYLAN PHARMACEUTICALS INC.]40Current NDC, Legacy NDC, 2 package rows20250523_737e0fac-a2d2-4053-a0d7-edbfb6248f69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310352fluconazole 10 MG in 1 mL Oral SuspensionPSN737e0fac-a2d2-4053-a0d7-edbfb6248f6943
197698fluconazole 100 MG Oral TabletPSN737e0fac-a2d2-4053-a0d7-edbfb6248f6943
197699fluconazole 150 MG Oral TabletPSN737e0fac-a2d2-4053-a0d7-edbfb6248f6943
197700fluconazole 200 MG Oral TabletPSN737e0fac-a2d2-4053-a0d7-edbfb6248f6943
310353fluconazole 40 MG in 1 mL Oral SuspensionPSN737e0fac-a2d2-4053-a0d7-edbfb6248f6943
197701fluconazole 50 MG Oral TabletPSN737e0fac-a2d2-4053-a0d7-edbfb6248f6943
310352fluconazole 10 MG/ML Oral SuspensionSCD737e0fac-a2d2-4053-a0d7-edbfb6248f6943
197698fluconazole 100 MG Oral TabletSCD737e0fac-a2d2-4053-a0d7-edbfb6248f6943
197699fluconazole 150 MG Oral TabletSCD737e0fac-a2d2-4053-a0d7-edbfb6248f6943
197700fluconazole 200 MG Oral TabletSCD737e0fac-a2d2-4053-a0d7-edbfb6248f6943
310353fluconazole 40 MG/ML Oral SuspensionSCD737e0fac-a2d2-4053-a0d7-edbfb6248f6943
197701fluconazole 50 MG Oral TabletSCD737e0fac-a2d2-4053-a0d7-edbfb6248f6943
310352fluconazole 10 MG per 1 ML Oral SuspensionSY737e0fac-a2d2-4053-a0d7-edbfb6248f6943
310352fluconazole 10 MG per ML Powder for Oral SuspensionSY737e0fac-a2d2-4053-a0d7-edbfb6248f6943
310353fluconazole 1400 MG per 35 ML Oral SuspensionSY737e0fac-a2d2-4053-a0d7-edbfb6248f6943
310353fluconazole 200 MG per 5 ML Oral SuspensionSY737e0fac-a2d2-4053-a0d7-edbfb6248f6943
310352fluconazole 350 MG per 35 ML Powder for Oral SuspensionSY737e0fac-a2d2-4053-a0d7-edbfb6248f6943
310353fluconazole 40 MG per 1 ML Oral SuspensionSY737e0fac-a2d2-4053-a0d7-edbfb6248f6943
310353fluconazole 40 MG per ML Powder for Oral SuspensionSY737e0fac-a2d2-4053-a0d7-edbfb6248f6943
310352fluconazole 50 MG per 5 ML Powder for Oral SuspensionSY737e0fac-a2d2-4053-a0d7-edbfb6248f6943
310352fluconazole 10 MG in 1 mL Oral SuspensionPSN926100a4-98b2-40ec-8592-56f86fa0cf2213
197698fluconazole 100 MG Oral TabletPSN926100a4-98b2-40ec-8592-56f86fa0cf2213
197699fluconazole 150 MG Oral TabletPSN926100a4-98b2-40ec-8592-56f86fa0cf2213
197700fluconazole 200 MG Oral TabletPSN926100a4-98b2-40ec-8592-56f86fa0cf2213
310353fluconazole 40 MG in 1 mL Oral SuspensionPSN926100a4-98b2-40ec-8592-56f86fa0cf2213
310352fluconazole 10 MG/ML Oral SuspensionSCD926100a4-98b2-40ec-8592-56f86fa0cf2213
197698fluconazole 100 MG Oral TabletSCD926100a4-98b2-40ec-8592-56f86fa0cf2213
197699fluconazole 150 MG Oral TabletSCD926100a4-98b2-40ec-8592-56f86fa0cf2213
197700fluconazole 200 MG Oral TabletSCD926100a4-98b2-40ec-8592-56f86fa0cf2213
310353fluconazole 40 MG/ML Oral SuspensionSCD926100a4-98b2-40ec-8592-56f86fa0cf2213
310352fluconazole 10 MG per 1 ML Oral SuspensionSY926100a4-98b2-40ec-8592-56f86fa0cf2213
310352fluconazole 10 MG per ML Powder for Oral SuspensionSY926100a4-98b2-40ec-8592-56f86fa0cf2213
310353fluconazole 1400 MG per 35 ML Oral SuspensionSY926100a4-98b2-40ec-8592-56f86fa0cf2213
310353fluconazole 200 MG per 5 ML Oral SuspensionSY926100a4-98b2-40ec-8592-56f86fa0cf2213
310352fluconazole 350 MG per 35 ML Powder for Oral SuspensionSY926100a4-98b2-40ec-8592-56f86fa0cf2213
310353fluconazole 40 MG per 1 ML Oral SuspensionSY926100a4-98b2-40ec-8592-56f86fa0cf2213
310353fluconazole 40 MG per ML Powder for Oral SuspensionSY926100a4-98b2-40ec-8592-56f86fa0cf2213
310352fluconazole 50 MG per 5 ML Powder for Oral SuspensionSY926100a4-98b2-40ec-8592-56f86fa0cf2213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-5029-1597625029011 BOTTLE in 1 CARTON (59762-5029-1) / 35 mL in 1 BOTTLE1 bottle1993-12-230000-00-00NoNoCurrent