Ketoconazole

Product NDC

68084-552

11-digit product format

680840552

Labeler code

68084

Product ID

68084-552_7d7650c0-9acc-0cfd-e053-2991aa0a3e3b

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

ketoconazole

Dosage form

TABLET

Route

ORAL

Labeler

American Health Packaging

Application

ANDA075597

Marketing category

ANDA

Marketing start

2011-12-21

Marketing end

2019-05-31

Substance

KETOCONAZOLE

Active strength

200 mg/1

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