KETOCONAZOLE
- Product NDC
- 50090-6142
- 11-digit product format
- 500906142
- Labeler code
- 50090
- Product ID
- 50090-6142_53e92009-965c-4487-9143-6ca9159893d6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketoconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA075912
- Marketing category
- ANDA
- Marketing start
- 2020-04-10
- 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
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| R9400W927I | KETOCONAZOLE | 65277-42-1 | KETOCONAZOLE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6142-1 | 50090614201 | 7 TABLET in 1 BOTTLE (50090-6142-1) | 7 tablet | 2022-10-03 | No | No | Historical |