KETOCONAZOLE
- Product NDC
- 71337-035
- 11-digit product format
- 713370035
- Labeler code
- 71337
- Product ID
- 71337-035_efe0105c-ddef-4d3b-9be9-f9ed478b0f03
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketoconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Havix Group Inc d-b-a Aavis Pharmaceuticals
- Application
- ANDA075912
- Marketing category
- ANDA
- Marketing start
- 2020-11-12
- 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
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71337-035-01 | 71337003501 | 100 TABLET in 1 BOTTLE (71337-035-01) | 100 tablet | 2020-11-13 | 0000-00-00 | No | No | Current |
| 71337-035-03 | 71337003503 | 30 TABLET in 1 BOTTLE (71337-035-03) | 30 tablet | 2020-11-13 | 0000-00-00 | No | No | Current |