Ketoconazole
- Product NDC
- 70518-3367
- 11-digit product format
- 705183367
- Labeler code
- 70518
- Product ID
- 70518-3367_e38cfa58-a49f-26fd-e053-2995a90a3a08
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA075581
- Marketing category
- ANDA
- Marketing start
- 2022-02-16
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3367-0 | 70518336700 | 1 TUBE in 1 CARTON (70518-3367-0) > 30 g in 1 TUBE | 1 tube | 2022-02-16 | 0000-00-00 | No | No | Current |