Ketaconazole
- Product NDC
- 0378-7007
- 11-digit product format
- 003787007
- Labeler code
- 0378
- Product ID
- 0378-7007_d7dc70c0-ca7d-42cc-bf8e-13dd6459ebb7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketaconazole
- Dosage form
- AEROSOL, FOAM
- Route
- TOPICAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA021738
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2018-12-20
- 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
- 2020-12-31
- 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 |
|---|
| 0378-7007-01 | 00378700701 | 1 CAN in 1 CARTON (0378-7007-01) > 100 g in 1 CAN | 1 can | 2018-12-20 | 0000-00-00 | No | No | Current |
| 0378-7007-50 | 00378700750 | 1 CAN in 1 CARTON (0378-7007-50) > 50 g in 1 CAN | 1 can | 2018-12-20 | 0000-00-00 | No | No | Current |