Nizoral

Product NDC

50458-680

11-digit product format

504580680

Labeler code

50458

Product ID

50458-680_fdce9da0-8109-11eb-af41-c816fc2ca371

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

ketoconazole

Dosage form

SHAMPOO

Route

TOPICAL

Labeler

Janssen Pharmaceuticals, Inc.

Application

NDA019927

Marketing category

NDA

Marketing start

1990-08-31

Marketing end

2022-03-04

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