Ketoconazole
- Product NDC
- 63629-8819
- 11-digit product format
- 636298819
- Labeler code
- 63629
- Product ID
- 63629-8819_d29922c6-7e4f-493c-97a7-182e7f415deb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA075581
- Marketing category
- ANDA
- Marketing start
- 2019-02-08
- 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
- 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 |
|---|
| 63629-8819-1 | 63629881901 | 1 TUBE in 1 CARTON (63629-8819-1) / 15 g in 1 TUBE | 1 tube | 2021-09-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ketoconazole Cream Rx only | Bryant Ranch Prepack | 2024-01-11 | HUMAN PRESCRIPTION DRUG LABEL | 102 |