fluconazole

Product NDC
71335-0686
11-digit product format
713350686
Labeler code
71335
Product ID
71335-0686_9734dcd0-c8ba-455b-89fa-e78063597742
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208963
Marketing category
ANDA
Marketing start
2017-04-06
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

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
71335-0686-0fluconazole60 in 1 BOTTLETABLET6014
71335-0686-1fluconazole2 in 1 BOTTLETABLET214
71335-0686-2fluconazole14 in 1 BOTTLETABLET1414
71335-0686-3fluconazole3 in 1 BOTTLETABLET314
71335-0686-4fluconazole6 in 1 BOTTLETABLET614
71335-0686-5fluconazole30 in 1 BOTTLETABLET3014
71335-0686-6fluconazole8 in 1 BOTTLETABLET814
71335-0686-7fluconazole1 in 1 BOTTLETABLET114
71335-0686-8fluconazole7 in 1 BOTTLETABLET714
71335-0686-9fluconazole10 in 1 BOTTLETABLET1014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0686FLUCONAZOLE TABLET [BRYANT RANCH PREPACK]14Current NDC, Legacy NDC, 10 package rows20240418_67af604c-928f-468b-ba27-ad45e95d3e7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSN67af604c-928f-468b-ba27-ad45e95d3e7e14
197698fluconazole 100 MG Oral TabletSCD67af604c-928f-468b-ba27-ad45e95d3e7e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0686-07133506860060 TABLET in 1 BOTTLE (71335-0686-0) 60 tablet2024-04-030000-00-00NoNoCurrent
71335-0686-1713350686012 TABLET in 1 BOTTLE (71335-0686-1) 2 tablet2018-11-060000-00-00NoNoCurrent
71335-0686-27133506860214 TABLET in 1 BOTTLE (71335-0686-2) 14 tablet2019-03-120000-00-00NoNoCurrent
71335-0686-3713350686033 TABLET in 1 BOTTLE (71335-0686-3) 3 tablet2018-06-040000-00-00NoNoCurrent
71335-0686-4713350686046 TABLET in 1 BOTTLE (71335-0686-4) 6 tablet2024-04-030000-00-00NoNoCurrent
71335-0686-57133506860530 TABLET in 1 BOTTLE (71335-0686-5) 30 tablet2019-08-050000-00-00NoNoCurrent
71335-0686-6713350686068 TABLET in 1 BOTTLE (71335-0686-6) 8 tablet2018-02-130000-00-00NoNoCurrent
71335-0686-7713350686071 TABLET in 1 BOTTLE (71335-0686-7) 1 tablet2021-11-090000-00-00NoNoCurrent
71335-0686-8713350686087 TABLET in 1 BOTTLE (71335-0686-8) 7 tablet2018-02-200000-00-00NoNoCurrent
71335-0686-97133506860910 TABLET in 1 BOTTLE (71335-0686-9) 10 tablet2018-08-230000-00-00NoNoCurrent