Fluconazole

Product NDC
71335-1948
11-digit product format
713351948
Labeler code
71335
Product ID
71335-1948_32c97d77-42fa-4dee-8597-86e0a08831c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078423
Marketing category
ANDA
Marketing start
2021-04-22
Substance
FLUCONAZOLE
Active strength
100 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
71335-1948-07133519480060 TABLET in 1 BOTTLE (71335-1948-0) 60 tablet2024-10-07NoNoHistorical
71335-1948-1713351948012 TABLET in 1 BOTTLE (71335-1948-1) 2 tablet2022-03-11NoNoHistorical
71335-1948-27133519480214 TABLET in 1 BOTTLE (71335-1948-2) 14 tablet2024-10-07NoNoHistorical
71335-1948-3713351948033 TABLET in 1 BOTTLE (71335-1948-3) 3 tablet2024-10-07NoNoHistorical
71335-1948-4713351948046 TABLET in 1 BOTTLE (71335-1948-4) 6 tablet2024-10-07NoNoHistorical
71335-1948-57133519480530 TABLET in 1 BOTTLE (71335-1948-5) 30 tablet2024-10-07NoNoHistorical
71335-1948-6713351948068 TABLET in 1 BOTTLE (71335-1948-6) 8 tablet2024-05-30NoNoHistorical
71335-1948-7713351948071 TABLET in 1 BOTTLE (71335-1948-7) 1 tablet2024-10-07NoNoHistorical
71335-1948-8713351948087 TABLET in 1 BOTTLE (71335-1948-8) 7 tablet2022-03-24NoNoHistorical
71335-1948-97133519480910 TABLET in 1 BOTTLE (71335-1948-9) 10 tablet2022-09-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Fluconazole Tablets USPBryant Ranch Prepack2025-10-06HUMAN PRESCRIPTION DRUG LABEL107
Fluconazole Tablets USPBryant Ranch Prepack2024-10-07HUMAN PRESCRIPTION DRUG LABEL106