FDA.reportPublic FDA data

Fluconazole

Product NDC
50090-5764
11-digit product format
500905764
Labeler code
50090
Product ID
50090-5764_d02789c9-d0d8-4d32-8b97-be24c2b26e44
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077253
Marketing category
ANDA
Marketing start
2020-11-20
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
Rxcui197699

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
74f0b828-cb79-42cb-bb6c-81c9f5bd2648Product name220250623
fe6bb120-ebc6-6290-9eab-e842fdb6c841Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5764-02023-02-06C16284748780-1f386c64a-093e-0266-e053-dadaa90a7c1aFluconazole Tablets
50090-5764-12023-02-06C16284748780-1f386c64a-093e-0266-e053-dadaa90a7c1aFluconazole Tablets
50090-5764-22023-02-06C16284748780-1f386c64a-093e-0266-e053-dadaa90a7c1aFluconazole Tablets
50090-5764-32023-02-06C16284748780-1f386c64a-093e-0266-e053-dadaa90a7c1aFluconazole Tablets
50090-5764-02023-01-30C16284748780-1f386c64a-093e-0266-e053-dadaa90a7c1aFluconazole Tablets
50090-5764-12023-01-30C16284748780-1f386c64a-093e-0266-e053-dadaa90a7c1aFluconazole Tablets
50090-5764-22023-01-30C16284748780-1f386c64a-093e-0266-e053-dadaa90a7c1aFluconazole Tablets
50090-5764-32023-01-30C16284748780-1f386c64a-093e-0266-e053-dadaa90a7c1aFluconazole Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5764-0Fluconazole1 in 1 BLISTER PACKTABLET15
50090-5764-0Fluconazole1 in 1 CARTONTABLET15
50090-5764-1Fluconazole1 in 1 BLISTER PACKTABLET15
50090-5764-1Fluconazole12 in 1 CARTONTABLET125
50090-5764-2Fluconazole2 in 1 CARTONTABLET25
50090-5764-2Fluconazole1 in 1 BLISTER PACKTABLET15
50090-5764-3Fluconazole1 in 1 BLISTER PACKTABLET15
50090-5764-3Fluconazole4 in 1 CARTONTABLET45

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5764-0EA - Each50090-5764201932d1-6a6b-4d8a-a322-f76e470cb32112022-12-07
50090-5764-1EA - Each50090-5764ea208516-32bf-48de-a7d3-8d70a141178812023-02-06
50090-5764-2EA - Each50090-57646bbf5ac6-923f-4af5-916e-5912ddcc24ca12022-12-07
50090-5764-3EA - Each50090-5764a9f4237c-b429-4702-9e39-a807a96cf29612022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5764FLUCONAZOLE TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 8 package rows20231204_2fcac0e4-4f12-42d2-b129-106b4e100075.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSN2fcac0e4-4f12-42d2-b129-106b4e1000755
197699fluconazole 150 MG Oral TabletSCD2fcac0e4-4f12-42d2-b129-106b4e1000755

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5764-0500905764001 BLISTER PACK in 1 CARTON (50090-5764-0) / 1 TABLET in 1 BLISTER PACK1 blister pack2021-10-040000-00-00NoNoCurrent
50090-5764-15009057640112 BLISTER PACK in 1 CARTON (50090-5764-1) / 1 TABLET in 1 BLISTER PACK12 blister pack2021-10-040000-00-00NoNoCurrent
50090-5764-2500905764022 BLISTER PACK in 1 CARTON (50090-5764-2) / 1 TABLET in 1 BLISTER PACK2 blister pack2021-10-040000-00-00NoNoCurrent
50090-5764-3500905764034 BLISTER PACK in 1 CARTON (50090-5764-3) / 1 TABLET in 1 BLISTER PACK4 blister pack2021-10-040000-00-00NoNoCurrent