Itraconazole
- Product NDC
- 0378-5100
- 11-digit product format
- 003785100
- Labeler code
- 0378
- Product ID
- 0378-5100_1b613520-d571-4999-b0ee-a689a334c053
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- itraconazole
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA200463
- Marketing category
- ANDA
- Marketing start
- 2012-07-26
- Marketing end
- 2023-06-30
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-5100-93 | 00378510093 | 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-5100-93) | 30 capsule | 2012-07-26 | 2023-06-30 | No | No | Current |