Xolegel
- Product NDC
- 16110-080
- 11-digit product format
- 161100080
- Labeler code
- 16110
- Product ID
- 16110-080_6655b621-f3b7-11eb-85b4-0800200c9a66
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketoconazole
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Almirall, LLC
- Application
- NDA021946
- Marketing category
- NDA
- Marketing start
- 2006-07-28
- Marketing end
- 0000-00-00
- Substance
- KETOCONAZOLE
- Active strength
- 20 mg/g
- 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
- 2022-12-31
- 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 |
|---|
| 16110-080-45 | 16110008045 | 1 TUBE in 1 CARTON (16110-080-45) > 45 g in 1 TUBE | 1 tube | 2006-07-28 | 0000-00-00 | No | No | Current |