FDA.reportPublic FDA data

Fluconazole

Product NDC
82804-146
11-digit product format
828040146
Labeler code
82804
Product ID
82804-146_df8a97c4-4546-48d0-b0f1-d0189224cea5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077731
Marketing category
ANDA
Marketing start
2008-10-07
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
82804-146-06Fluconazole6 in 1 BOTTLETABLET62
82804-146-30Fluconazole30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-146-30EA - Each82804-146dacfac78-c8fb-4f45-8784-494fa1b058fa12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-146FLUCONAZOLE TABLET [PROFICIENT RX LP]1Current NDC, 2 package rows20241020_fef2222c-5d61-435e-8761-d8f3d435d6d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197700fluconazole 200 MG Oral TabletPSNfef2222c-5d61-435e-8761-d8f3d435d6d82
197700fluconazole 200 MG Oral TabletSCDfef2222c-5d61-435e-8761-d8f3d435d6d82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-146-06828040146066 TABLET in 1 BOTTLE (82804-146-06) 6 tablet2025-09-08NoNoCurrent
82804-146-308280401463030 TABLET in 1 BOTTLE (82804-146-30) 30 tablet2024-10-04NoNoCurrent