Onmel

Product NDC

0259-1420

11-digit product format

002591420

Labeler code

0259

Product ID

0259-1420_80a08006-3d71-85df-e053-2991aa0aaaf7

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

ITRACONAZOLE

Dosage form

TABLET

Route

ORAL

Labeler

Merz Pharmaceuticals, LLC

Application

NDA022484

Marketing category

NDA

Marketing start

2012-11-01

Marketing end

2020-11-30

Substance

ITRACONAZOLE

Active strength

200 mg/1

Pharmacologic classes

Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record