fluconazole

Product NDC
71335-0769
11-digit product format
713350769
Labeler code
71335
Product ID
71335-0769_b23c4215-a8ba-44ec-8c42-23be80e7953e
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
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
Rxcui197700

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
71335-0769-0fluconazole4 in 1 BOTTLETABLET4103
71335-0769-1fluconazole30 in 1 BOTTLETABLET30103
71335-0769-2fluconazole12 in 1 BOTTLETABLET12103
71335-0769-3fluconazole100 in 1 BOTTLETABLET100103
71335-0769-4fluconazole3 in 1 BOTTLETABLET3103
71335-0769-5fluconazole28 in 1 BOTTLETABLET28103
71335-0769-6fluconazole1 in 1 BOTTLETABLET1103
71335-0769-7fluconazole2 in 1 BOTTLETABLET2103
71335-0769-8fluconazole14 in 1 BOTTLETABLET14103
71335-0769-9fluconazole8 in 1 BOTTLETABLET8103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0769FLUCONAZOLE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 10 package rows20240410_7259671f-a703-4a2a-81db-9a4839b34072.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197700fluconazole 200 MG Oral TabletPSN7259671f-a703-4a2a-81db-9a4839b34072103
197700fluconazole 200 MG Oral TabletSCD7259671f-a703-4a2a-81db-9a4839b34072103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0769-0713350769004 TABLET in 1 BOTTLE (71335-0769-0) 4 tablet2019-02-220000-00-00NoNoCurrent
71335-0769-17133507690130 TABLET in 1 BOTTLE (71335-0769-1) 30 tablet2018-04-100000-00-00NoNoCurrent
71335-0769-27133507690212 TABLET in 1 BOTTLE (71335-0769-2) 12 tablet2018-10-170000-00-00NoNoCurrent
71335-0769-371335076903100 TABLET in 1 BOTTLE (71335-0769-3) 100 tablet2024-04-030000-00-00NoNoCurrent
71335-0769-4713350769043 TABLET in 1 BOTTLE (71335-0769-4) 3 tablet2024-04-030000-00-00NoNoCurrent
71335-0769-57133507690528 TABLET in 1 BOTTLE (71335-0769-5) 28 tablet2024-04-030000-00-00NoNoCurrent
71335-0769-6713350769061 TABLET in 1 BOTTLE (71335-0769-6) 1 tablet2022-06-210000-00-00NoNoCurrent
71335-0769-7713350769072 TABLET in 1 BOTTLE (71335-0769-7) 2 tablet2018-04-260000-00-00NoNoCurrent
71335-0769-87133507690814 TABLET in 1 BOTTLE (71335-0769-8) 14 tablet2019-02-210000-00-00NoNoCurrent
71335-0769-9713350769098 TABLET in 1 BOTTLE (71335-0769-9) 8 tablet2019-03-080000-00-00NoNoCurrent