Ketoconazole
- Product NDC
- 85766-135
- 11-digit product format
- 857660135
- Labeler code
- 85766
- Product ID
- 85766-135_48cb3cef-417e-1ad7-e063-6294a90a2620
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole Cream, 2%
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Sportpharm LLC
- Application
- ANDA212443
- Marketing category
- ANDA
- Marketing start
- 2021-05-27
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ketoconazole
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETOCONAZOLE | 20 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R9400W927I |
| Rxcui | 203088 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85766-135-15 | 85766013515 | 1 TUBE in 1 CARTON (85766-135-15) / 15 g in 1 TUBE | 1 tube | 2026-01-20 | No | No | Historical |
| 85766-135-30 | 85766013530 | 1 TUBE in 1 CARTON (85766-135-30) / 30 g in 1 TUBE | 1 tube | 2026-01-20 | No | No | Historical |
| 85766-135-60 | 85766013560 | 1 TUBE in 1 CARTON (85766-135-60) / 60 g in 1 TUBE | 1 tube | 2026-01-20 | No | No | Historical |