FDA.reportPublic FDA data

Fluconazole

Product NDC
16714-692
11-digit product format
167140692
Labeler code
16714
Product ID
16714-692_06bbf63a-4457-4206-af05-246be0ddb301
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA077731
Marketing category
ANDA
Marketing start
2008-10-07
Substance
FLUCONAZOLE
Active strength
150 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
FLUCONAZOLE150 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
16714-692-10Fluconazole1 in 1 BLISTER PACKTABLET119
16714-692-11Fluconazole12 in 1 CARTONTABLET1219

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-692-10EA - Each16714-6920d028215-60b4-4b60-ac60-c65a4f4573a912014-01-04
16714-692-11EA - Each16714-692c9c5b78c-9794-45e8-81ce-862ec82bdcfc12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE TABLET [NORTHSTAR RX LLC]5
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE TABLET [NORTHSTAR RX LLC]5
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JFLUCONAZOLE TABLET [NORTHSTAR RX LLC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUCONAZOLE TABLET [NORTHSTAR RX LLC]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUCONAZOLE TABLET [NORTHSTAR RX LLC]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUCONAZOLE TABLET [NORTHSTAR RX LLC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUCONAZOLE TABLET [NORTHSTAR RX LLC]5
POVIDONE K30INACTIVE INGREDIENTU725QWY32XFLUCONAZOLE TABLET [NORTHSTAR RX LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-692FLUCONAZOLE TABLET [NORTHSTAR RX LLC]19Current NDC, Legacy NDC, 2 package rows20240809_d2acccda-8068-46c1-8562-950d7f70ee06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSNd2acccda-8068-46c1-8562-950d7f70ee0619
197699fluconazole 150 MG Oral TabletPSNd2acccda-8068-46c1-8562-950d7f70ee0619
197700fluconazole 200 MG Oral TabletPSNd2acccda-8068-46c1-8562-950d7f70ee0619
197701fluconazole 50 MG Oral TabletPSNd2acccda-8068-46c1-8562-950d7f70ee0619
197698fluconazole 100 MG Oral TabletSCDd2acccda-8068-46c1-8562-950d7f70ee0619
197699fluconazole 150 MG Oral TabletSCDd2acccda-8068-46c1-8562-950d7f70ee0619
197700fluconazole 200 MG Oral TabletSCDd2acccda-8068-46c1-8562-950d7f70ee0619
197701fluconazole 50 MG Oral TabletSCDd2acccda-8068-46c1-8562-950d7f70ee0619
197699fluconazole 150 MG Oral TabletPSNf25f31a6-4bad-40fa-bced-695552e27afd11
197699fluconazole 150 MG Oral TabletSCDf25f31a6-4bad-40fa-bced-695552e27afd11
197699fluconazole 150 MG Oral TabletPSN88d9904c-0c21-4188-95e2-6479bdf359df5
197699fluconazole 150 MG Oral TabletSCD88d9904c-0c21-4188-95e2-6479bdf359df5
197699fluconazole 150 MG Oral TabletPSN60f3e8af-d98f-48dd-83e6-a78315aaed221
197699fluconazole 150 MG Oral TabletSCD60f3e8af-d98f-48dd-83e6-a78315aaed221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-692-10167140692101 in 1 BLISTER PACKHistorical
16714-692-111671406921112 BLISTER PACK in 1 CARTON (16714-692-11) / 1 TABLET in 1 BLISTER PACK (16714-692-10) 12 blister pack2008-10-070000-00-00NoNoCurrent