Itraconazole
- Product NDC
- 63629-8168
- 11-digit product format
- 636298168
- Labeler code
- 63629
- Product ID
- 63629-8168_54e8ff12-94d9-456d-ae5d-a32ca187e380
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Itraconazole
- Dosage form
- CAPSULE, COATED PELLETS
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA208591
- Marketing category
- ANDA
- Marketing start
- 2017-06-12
- Marketing end
- 0000-00-00
- Substance
- ITRACONAZOLE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-8168-1 | 63629816801 | 30 CAPSULE, COATED PELLETS in 1 BOTTLE (63629-8168-1) | 2019-07-12 | 0000-00-00 | No | No | Current |