KETOCONAZOLE

Product NDC

10147-0750

11-digit product format

101470750

Labeler code

10147

Product ID

10147-0750_f3415c6c-67f0-11e9-81ce-c7f80099106d

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

ketoconazole

Dosage form

SHAMPOO

Route

TOPICAL

Labeler

Patriot Pharmaceuticals, LLC

Application

NDA019927

Marketing category

NDA AUTHORIZED GENERIC

Marketing start

2005-07-01

Marketing end

2020-09-30

Substance

KETOCONAZOLE

Active strength

20 mg/mL

Pharmacologic classes

Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record