FDA.reportPublic FDA data

Fluconazole

Product NDC
68001-253
11-digit product format
680010253
Labeler code
68001
Product ID
68001-253_472a93c7-fd2a-f837-e063-6294a90aed1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA077253
Marketing category
ANDA
Marketing start
2014-03-13
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
68001-253-17Fluconazole12 in 1 CARTONTABLET1220
68001-253-20Fluconazole12 in 1 CARTONTABLET1220
68001-253-21Fluconazole1 in 1 BLISTER PACKTABLET120
68001-253-44Fluconazole1 in 1 BLISTER PACKTABLET120

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-253-17EA - Each68001-253916c50fe-5eb4-4af1-864d-4815f169fa9c12021-12-08
68001-253-20EA - Each68001-253d10671d6-1dfd-4168-8dd4-5e65a14a5ba112014-05-02
68001-253-21EA - Each68001-253beac3d5b-853c-4f5f-979f-105f7ca5f72212014-05-02
68001-253-44EA - Each68001-253c6b63a82-ee57-4b42-b089-de1328233b9712021-12-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUCONAZOLEACTIVE INGREDIENT8VZV102JFYFLUCONAZOLE TABLET [BLUEPOINT LABORATORIES]5
FLUCONAZOLEACTIVE MOIETY8VZV102JFYFLUCONAZOLE TABLET [BLUEPOINT LABORATORIES]5
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JFLUCONAZOLE TABLET [BLUEPOINT LABORATORIES]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLUCONAZOLE TABLET [BLUEPOINT LABORATORIES]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUCONAZOLE TABLET [BLUEPOINT LABORATORIES]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUCONAZOLE TABLET [BLUEPOINT LABORATORIES]5
POVIDONESINACTIVE INGREDIENTFZ989GH94EFLUCONAZOLE TABLET [BLUEPOINT LABORATORIES]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-253FLUCONAZOLE TABLET [BLUEPOINT LABORATORIES]19Current NDC, Legacy NDC, 4 package rows20240621_83bcb8fc-53f1-4d7b-b083-0905b52c6c7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSN83bcb8fc-53f1-4d7b-b083-0905b52c6c7e20
197699fluconazole 150 MG Oral TabletPSN83bcb8fc-53f1-4d7b-b083-0905b52c6c7e20
197700fluconazole 200 MG Oral TabletPSN83bcb8fc-53f1-4d7b-b083-0905b52c6c7e20
197701fluconazole 50 MG Oral TabletPSN83bcb8fc-53f1-4d7b-b083-0905b52c6c7e20
197698fluconazole 100 MG Oral TabletSCD83bcb8fc-53f1-4d7b-b083-0905b52c6c7e20
197699fluconazole 150 MG Oral TabletSCD83bcb8fc-53f1-4d7b-b083-0905b52c6c7e20
197700fluconazole 200 MG Oral TabletSCD83bcb8fc-53f1-4d7b-b083-0905b52c6c7e20
197701fluconazole 50 MG Oral TabletSCD83bcb8fc-53f1-4d7b-b083-0905b52c6c7e20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-253-176800102531712 BLISTER PACK in 1 CARTON (68001-253-17) / 1 TABLET in 1 BLISTER PACK (68001-253-44) 12 blister pack2021-06-300000-00-00NoNoCurrent
68001-253-206800102532012 BLISTER PACK in 1 CARTON (68001-253-20) > 1 TABLET in 1 BLISTER PACK (68001-253-21) 12 blister pack2014-03-130000-00-00NoNoCurrent
68001-253-21680010253211 in 1 BLISTER PACKHistorical
68001-253-44680010253441 in 1 BLISTER PACKHistorical