FDA.reportPublic FDA data

Fluconazole

Product NDC
16714-691
11-digit product format
167140691
Labeler code
16714
Product ID
16714-691_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
100 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
FLUCONAZOLE100 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
16714-691-01Fluconazole30 in 1 BOTTLETABLET3019
16714-691-02Fluconazole100 in 1 BOTTLETABLET10019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-691-01EA - Each16714-6917f3d6b9e-7c53-4ca7-a5ff-f1b0c20ed72012013-12-02
16714-691-02EA - Each16714-691e1e1024a-c62b-47fc-b24b-4b3b2f81888f12013-12-02

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
16714-691FLUCONAZOLE 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
197698fluconazole 100 MG Oral TabletPSN2bd1c038-ab82-496c-8129-3182238ad1a12
197698fluconazole 100 MG Oral TabletSCD2bd1c038-ab82-496c-8129-3182238ad1a12
197698fluconazole 100 MG Oral TabletPSN2b9b08b6-7239-473b-e063-6294a90ab7c41
197698fluconazole 100 MG Oral TabletSCD2b9b08b6-7239-473b-e063-6294a90ab7c41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-691-011671406910130 TABLET in 1 BOTTLE (16714-691-01) 30 tablet2008-10-070000-00-00NoNoCurrent
16714-691-0216714069102100 TABLET in 1 BOTTLE (16714-691-02) 100 tablet2008-10-070000-00-00NoNoCurrent