Fluconazole

Product NDC

49999-520

11-digit product format

499990520

Labeler code

49999

Product ID

49999-520_4efec3eb-da83-40d6-9a6f-8cf9ae2b05d4

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Fluconazole

Dosage form

TABLET

Route

ORAL

Labeler

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

Application

ANDA077253

Marketing category

ANDA

Marketing start

2012-03-07

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

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record