Ketoconazole
- Product NDC
- 53002-8150
- 11-digit product format
- 530028150
- Labeler code
- 53002
- Product ID
- 53002-8150_81214d50-bf77-4009-9ca9-32149131ca57
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA075638
- Marketing category
- ANDA
- Marketing start
- 2002-12-18
- Marketing end
- 0000-00-00
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-8150-1 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-a1a7-f424-e053-dadaa90a57ce | Ketoconazole Cream, 2% |
| 53002-8150-2 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-a1a7-f424-e053-dadaa90a57ce | Ketoconazole Cream, 2% |
| 53002-8150-1 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-a1a7-f424-e053-dadaa90a57ce | Ketoconazole Cream, 2% |
| 53002-8150-2 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-a1a7-f424-e053-dadaa90a57ce | Ketoconazole Cream, 2% |
| 53002-8150-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-a1a7-f424-e053-dadaa90a57ce | Ketoconazole Cream, 2% |
| 53002-8150-2 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-a1a7-f424-e053-dadaa90a57ce | Ketoconazole Cream, 2% |
| 53002-8150-1 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d0-a1a7-f424-e053-dadaa90a57ce | Ketoconazole Cream, 2% |
| 53002-8150-2 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d0-a1a7-f424-e053-dadaa90a57ce | Ketoconazole Cream, 2% |
| 53002-8150-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a1a7-f424-e053-dadaa90a57ce | Ketoconazole Cream, 2% |
| 53002-8150-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a1a7-f424-e053-dadaa90a57ce | Ketoconazole Cream, 2% |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-8150-1 | Ketoconazole | 15 g in 1 TUBE | CREAM | 15 | | 5 |
| 53002-8150-2 | Ketoconazole | 30 g in 1 TUBE | CREAM | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-8150 | KETOCONAZOLE CREAM [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 2 package rows | 20230609_c2a85a63-793f-4354-80a7-c475ae7bdfb5.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 |
|---|
| 53002-8150-1 | 53002815001 | 15 g in 1 TUBE (53002-8150-1) | 15 g | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-8150-2 | 53002815002 | 30 g in 1 TUBE (53002-8150-2) | 30 g | 2018-10-01 | 0000-00-00 | No | No | Current |