Ketoconazole Cream
- Product NDC
- 72189-422
- 11-digit product format
- 721890422
- Labeler code
- 72189
- Product ID
- 72189-422_4d3a9c62-805c-df8c-e063-6294a90aa498
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole Cream
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Direct_Rx
- Application
- ANDA212443
- Marketing category
- ANDA
- Marketing start
- 2023-02-07
- 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 Cream
- 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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-422-30 | Ketoconazole Cream | 30 g in 1 TUBE | CREAM | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-422 | KETOCONAZOLE CREAM CREAM [DIRECT_RX] | 2 | Current NDC, 1 package rows | 20250123_f422aaa8-3cce-5989-e053-2a95a90a5205.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-422-30 | 72189042230 | 30 g in 1 TUBE (72189-422-30) | 30 g | 2023-02-07 | No | No | Current |