Fluconazole

Product NDC
71205-796
11-digit product format
712050796
Labeler code
71205
Product ID
71205-796_fa2fa2f8-f3a6-4bc0-943c-03dabd0f1581
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluconazole
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077253
Marketing category
ANDA
Marketing start
2020-11-20
Substance
FLUCONAZOLE
Active strength
150 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
71205-796-01712050796011 BLISTER PACK in 1 BAG (71205-796-01) / 1 TABLET in 1 BLISTER PACK1 blister pack2023-04-28NoNoHistorical
71205-796-02712050796022 BLISTER PACK in 1 BAG (71205-796-02) / 1 TABLET in 1 BLISTER PACK2 blister pack2023-04-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Fluconazole TabletsProficient Rx LP2023-04-01HUMAN PRESCRIPTION DRUG LABEL1