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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
8VZV102JFYFLUCONAZOLE86386-73-4FLUCONAZOLE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-146-06828040146066 TABLET in 1 BOTTLE (82804-146-06) 6 tablet2025-09-08NoNoHistorical
82804-146-308280401463030 TABLET in 1 BOTTLE (82804-146-30) 30 tablet2024-10-04NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Fluconazole Tablets USP Rx onlyProficient Rx LP2025-09-01HUMAN PRESCRIPTION DRUG LABEL2