Ketoconazole
- Product NDC
- 63187-774
- 11-digit product format
- 631870774
- Labeler code
- 63187
- Product ID
- 63187-774_b8de64ec-7114-42c5-a6c6-ee1122b05bf9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Proficient Rx LP
- Application
- ANDA075638
- Marketing category
- ANDA
- Marketing start
- 2002-12-18
- 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 |
|---|
| 63187-774-15 | 63187077415 | 1 TUBE in 1 CARTON (63187-774-15) / 15 g in 1 TUBE | 1 tube | 2016-11-01 | No | No | Historical |
| 63187-774-30 | 63187077430 | 1 TUBE in 1 CARTON (63187-774-30) / 30 g in 1 TUBE | 1 tube | 2016-11-01 | No | No | Historical |
| 63187-774-60 | 63187077460 | 1 TUBE in 1 CARTON (63187-774-60) / 60 g in 1 TUBE | 1 tube | 2016-11-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ketoconazole Cream, 2% | Proficient Rx LP | 2022-04-01 | HUMAN PRESCRIPTION DRUG LABEL | 5 |