Fluconazole

Product NDC
71335-1895
11-digit product format
713351895
Labeler code
71335
Product ID
71335-1895_0a2b1160-1a6c-414e-91b5-f3d2e3657c1f
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
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
71335-1895-0713351895004 TABLET in 1 BOTTLE (71335-1895-0) 4 tablet2024-10-07NoNoHistorical
71335-1895-17133518950130 TABLET in 1 BOTTLE (71335-1895-1) 30 tablet2021-11-30NoNoHistorical
71335-1895-27133518950212 TABLET in 1 BOTTLE (71335-1895-2) 12 tablet2021-10-22NoNoHistorical
71335-1895-371335189503100 TABLET in 1 BOTTLE (71335-1895-3) 100 tablet2024-10-07NoNoHistorical
71335-1895-4713351895043 TABLET in 1 BOTTLE (71335-1895-4) 3 tablet2024-10-07NoNoHistorical
71335-1895-57133518950528 TABLET in 1 BOTTLE (71335-1895-5) 28 tablet2024-10-07NoNoHistorical
71335-1895-6713351895061 TABLET in 1 BOTTLE (71335-1895-6) 1 tablet2024-10-07NoNoHistorical
71335-1895-7713351895072 TABLET in 1 BOTTLE (71335-1895-7) 2 tablet2021-10-04NoNoHistorical
71335-1895-87133518950814 TABLET in 1 BOTTLE (71335-1895-8) 14 tablet2022-04-25NoNoHistorical
71335-1895-9713351895098 TABLET in 1 BOTTLE (71335-1895-9) 8 tablet2024-10-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Fluconazole Tablets USPBryant Ranch Prepack2024-10-07HUMAN PRESCRIPTION DRUG LABEL105