Ketoconazole
- Product NDC
- 68788-9708
- 11-digit product format
- 687889708
- Labeler code
- 68788
- Product ID
- 68788-9708_cf776939-7ebf-4945-b3a2-43e201ad8169
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA075319
- Marketing category
- ANDA
- Marketing start
- 2013-02-05
- Marketing end
- 0000-00-00
- Substance
- KETOCONAZOLE
- Active strength
- 200 mg/1
- 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
- 2021-12-31
- 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 |
|---|
| 68788-9708-1 | 68788970801 | 10 TABLET in 1 BOTTLE (68788-9708-1) | 10 tablet | 2013-02-05 | 0000-00-00 | No | No | Current |
| 68788-9708-3 | 68788970803 | 30 TABLET in 1 BOTTLE (68788-9708-3) | 30 tablet | 2013-02-05 | 0000-00-00 | No | No | Current |
| 68788-9708-6 | 68788970806 | 60 TABLET in 1 BOTTLE (68788-9708-6) | 60 tablet | 2013-02-05 | 0000-00-00 | No | No | Current |