FDA.reportPublic FDA data

Fluconazole

Product NDC
50090-2195
11-digit product format
500902195
Labeler code
50090
Product ID
50090-2195_0eaa42bc-0006-47e5-a302-1c369883f0fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077731
Marketing category
ANDA
Marketing start
2008-10-07
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
50090-2195-02023-02-07C16284748780-1f386c649-e4ff-0266-e053-dadaa90a7c1aFluconazole Tablets USP Rx only
50090-2195-12023-02-07C16284748780-1f386c649-e4ff-0266-e053-dadaa90a7c1aFluconazole Tablets USP Rx only
50090-2195-22023-02-07C16284748780-1f386c649-e4ff-0266-e053-dadaa90a7c1aFluconazole Tablets USP Rx only
50090-2195-32023-02-07C16284748780-1f386c649-e4ff-0266-e053-dadaa90a7c1aFluconazole Tablets USP Rx only
50090-2195-02023-01-30C16284748780-1f386c649-e4ff-0266-e053-dadaa90a7c1aFluconazole Tablets USP Rx only
50090-2195-12023-01-30C16284748780-1f386c649-e4ff-0266-e053-dadaa90a7c1aFluconazole Tablets USP Rx only
50090-2195-22023-01-30C16284748780-1f386c649-e4ff-0266-e053-dadaa90a7c1aFluconazole Tablets USP Rx only
50090-2195-32023-01-30C16284748780-1f386c649-e4ff-0266-e053-dadaa90a7c1aFluconazole Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2195-0Fluconazole1 in 1 BLISTER PACKTABLET112
50090-2195-0Fluconazole1 in 1 CARTONTABLET112
50090-2195-1Fluconazole1 in 1 CARTONTABLET112
50090-2195-1Fluconazole12 in 1 BLISTER PACKTABLET1212
50090-2195-2Fluconazole2 in 1 BLISTER PACKTABLET212
50090-2195-2Fluconazole1 in 1 CARTONTABLET112
50090-2195-3Fluconazole1 in 1 CARTONTABLET112
50090-2195-3Fluconazole4 in 1 BLISTER PACKTABLET412

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2195-0EA - Each50090-2195d310e622-7915-441c-afd6-8b235891167412021-08-05
50090-2195-1EA - Each50090-21959551a7b3-60cf-4cb1-a2e4-3f3e18552f6a12024-12-10
50090-2195-2EA - Each50090-21950f9726ae-5743-4fa1-8b4d-16cb6c5788b712021-09-07
50090-2195-3EA - Each50090-21958126d907-080d-433e-ba1d-952bd169534312024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2195FLUCONAZOLE TABLET [A-S MEDICATION SOLUTIONS]12Current NDC, Legacy NDC, 8 package rows20241120_177322f4-9526-40cb-9e5d-bc24e8fb02db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197699fluconazole 150 MG Oral TabletPSN177322f4-9526-40cb-9e5d-bc24e8fb02db12
197699fluconazole 150 MG Oral TabletSCD177322f4-9526-40cb-9e5d-bc24e8fb02db12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2195-0500902195001 BLISTER PACK in 1 CARTON (50090-2195-0) / 1 TABLET in 1 BLISTER PACK1 blister pack2015-10-270000-00-00NoNoCurrent
50090-2195-1500902195011 BLISTER PACK in 1 CARTON (50090-2195-1) / 12 TABLET in 1 BLISTER PACK1 blister pack2015-10-270000-00-00NoNoCurrent
50090-2195-2500902195021 BLISTER PACK in 1 CARTON (50090-2195-2) / 2 TABLET in 1 BLISTER PACK1 blister pack2015-10-270000-00-00NoNoCurrent
50090-2195-3500902195031 BLISTER PACK in 1 CARTON (50090-2195-3) / 4 TABLET in 1 BLISTER PACK1 blister pack2019-11-050000-00-00NoNoCurrent