Itraconazole
- Product NDC
- 42543-113
- 11-digit product format
- 425430113
- Labeler code
- 42543
- Product ID
- 42543-113_664190f4-1b7c-457b-855e-575ee2bedba5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Itraconazole
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Vensun Pharmaceuticals, Inc.
- Application
- ANDA206410
- Marketing category
- ANDA
- Marketing start
- 2020-01-31
- Marketing end
- 0000-00-00
- Substance
- ITRACONAZOLE
- Active strength
- 100 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record