Fluconazole

Product NDC

55700-490

11-digit product format

557000490

Labeler code

55700

Product ID

55700-490_3843d771-7bbe-481a-8272-bb9a4402e8db

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Fluconazole

Dosage form

TABLET

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA078423

Marketing category

ANDA

Marketing start

2011-03-07

Marketing end

0000-00-00

Substance

FLUCONAZOLE

Active strength

100 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

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record