Ketoconazole

Product NDC

68071-4012

11-digit product format

680714012

Labeler code

68071

Product ID

68071-4012_55140bff-58d3-3ae2-e054-00144ff88e88

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Ketoconazole

Dosage form

TABLET

Route

ORAL

Labeler

NuCare Pharmaceuticals, Inc.

Application

ANDA075319

Marketing category

ANDA

Marketing start

1999-06-15

Marketing end

0000-00-00

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

2019-12-31

Current FDA listing

Historical FDA.report record