Ketoconazole
- Product NDC
- 21922-025
- 11-digit product format
- 219220025
- Labeler code
- 21922
- Product ID
- 21922-025_21342f09-ce90-49aa-9660-63e01b602ab7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole Cream, 2%
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Encube Ethicals, Inc.
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ketoconazole
- Listing expiration
- 2026-12-31
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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21922-025 | KETOCONAZOLE (KETOCONAZOLE CREAM, 2%) CREAM [ENCUBE ETHICALS PRIVATE LIMITED] | 4 | Current NDC, Legacy NDC, 6 package rows | 20250101_59188ef7-5bc9-4acc-bbff-8712c41e5f77.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 21922-025-04 | 21922002504 | 1 TUBE in 1 CARTON (21922-025-04) / 15 g in 1 TUBE | 1 tube | 2021-05-27 | 0000-00-00 | No | No | Current |
| 21922-025-05 | 21922002505 | 1 TUBE in 1 CARTON (21922-025-05) / 30 g in 1 TUBE | 1 tube | 2021-05-27 | 0000-00-00 | No | No | Current |
| 21922-025-07 | 21922002507 | 1 TUBE in 1 CARTON (21922-025-07) / 60 g in 1 TUBE | 1 tube | 2021-05-27 | 0000-00-00 | No | No | Current |