Fluconazole

Product NDC
68084-735
11-digit product format
680840735
Labeler code
68084
Product ID
68084-735_3a9f252b-e283-4d19-e063-6294a90a05ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA077731
Marketing category
ANDA
Marketing start
2014-09-03
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
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
FLUCONAZOLE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8VZV102JFY
Rxcui197698, 197700

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
68084-735-01Fluconazole100 in 1 BOX, UNIT-DOSETABLET10012
68084-735-11Fluconazole1 in 1 BLISTER PACKTABLET112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-735-01EA - Each68084-735657e3eb7-d9f2-42c4-8dc6-325161bef75912014-10-03
68084-735-11EA - Each68084-7357460fb53-704c-4063-87b5-8f2278b765e512014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]3
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JFLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EFLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-735FLUCONAZOLE TABLET [AMERICAN HEALTH PACKAGING]10Current NDC, Legacy NDC, 2 package rows20240816_d7aacee3-9d9c-4b36-b735-39bcb9edf941.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSNd7aacee3-9d9c-4b36-b735-39bcb9edf94112
197700fluconazole 200 MG Oral TabletPSNd7aacee3-9d9c-4b36-b735-39bcb9edf94112
197698fluconazole 100 MG Oral TabletSCDd7aacee3-9d9c-4b36-b735-39bcb9edf94112
197700fluconazole 200 MG Oral TabletSCDd7aacee3-9d9c-4b36-b735-39bcb9edf94112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-735-0168084073501100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-735-01) / 1 TABLET in 1 BLISTER PACK (68084-735-11) 100 blister pack2014-09-030000-00-00NoNoCurrent
68084-735-11680840735111 in 1 BLISTER PACKHistorical