Fluconazole

Product NDC
61919-493
11-digit product format
619190493
Labeler code
61919
Product ID
61919-493_0e88c9e2-8dbd-917c-e063-6294a90a6ec9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA208963
Marketing category
ANDA
Marketing start
2019-04-08
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
61919-493-03619190493033 TABLET in 1 BOTTLE (61919-493-03) 3 tablet2019-04-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
FluconazoleDirect Rx2024-01-09HUMAN PRESCRIPTION DRUG LABEL6