Fluconazole

Product NDC

10544-855

11-digit product format

105440855

Labeler code

10544

Product ID

10544-855_1467b4ed-05ef-6147-e054-00144ff8d46c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Fluconazole

Dosage form

TABLET

Route

ORAL

Labeler

Blenheim Pharmacal, Inc.

Application

ANDA077253

Marketing category

ANDA

Marketing start

2015-04-22

Marketing end

0000-00-00

Substance

FLUCONAZOLE

Active strength

150 mg/1

Pharmacologic classes

Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record