FDA.reportPublic FDA data

fluconazole

Product NDC
70771-1064
11-digit product format
707711064
Labeler code
70771
Product ID
70771-1064_4813fe26-a1f0-4782-a210-c669ae1ad899
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
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, 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
70771-1064-1fluconazole100 in 1 BOTTLETABLET10010
70771-1064-3fluconazole30 in 1 BOTTLETABLET3010
70771-1064-4fluconazole10 in 1 CARTONTABLET1010
70771-1064-4fluconazole10 in 1 BLISTER PACKTABLET1010
70771-1064-5fluconazole500 in 1 BOTTLETABLET50010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1064FLUCONAZOLE TABLET [ZYDUS LIFESCIENCES LIMITED]10Current NDC, Legacy NDC, 5 package rows20240306_0adb2f88-8a6f-4f33-9e2d-73f537e05313.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197698fluconazole 100 MG Oral TabletPSN0adb2f88-8a6f-4f33-9e2d-73f537e0531310
197699fluconazole 150 MG Oral TabletPSN0adb2f88-8a6f-4f33-9e2d-73f537e0531310
197700fluconazole 200 MG Oral TabletPSN0adb2f88-8a6f-4f33-9e2d-73f537e0531310
197701fluconazole 50 MG Oral TabletPSN0adb2f88-8a6f-4f33-9e2d-73f537e0531310
197698fluconazole 100 MG Oral TabletSCD0adb2f88-8a6f-4f33-9e2d-73f537e0531310
197699fluconazole 150 MG Oral TabletSCD0adb2f88-8a6f-4f33-9e2d-73f537e0531310
197700fluconazole 200 MG Oral TabletSCD0adb2f88-8a6f-4f33-9e2d-73f537e0531310
197701fluconazole 50 MG Oral TabletSCD0adb2f88-8a6f-4f33-9e2d-73f537e0531310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1064-170771106401100 TABLET in 1 BOTTLE (70771-1064-1) 100 tablet2017-04-060000-00-00NoNoCurrent
70771-1064-37077110640330 TABLET in 1 BOTTLE (70771-1064-3) 30 tablet2017-04-060000-00-00NoNoCurrent
70771-1064-47077110640410 BLISTER PACK in 1 CARTON (70771-1064-4) / 10 TABLET in 1 BLISTER PACK10 blister pack2017-04-060000-00-00NoNoCurrent
70771-1064-570771106405500 TABLET in 1 BOTTLE (70771-1064-5) 500 tablet2017-04-060000-00-00NoNoCurrent