Ketoconazole
- Product NDC
- 21695-554
- 11-digit product format
- 216950554
- Labeler code
- 21695
- Product ID
- 21695-554_836ebf14-fb11-45c3-9e0c-db1bebcd0f5b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Rebel Distributors Corp
- 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
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21695-554-15 | Ketoconazole | 1 in 1 CARTON | CREAM | 1 | | 1 |
| 21695-554-15 | Ketoconazole | 15 g in 1 TUBE | CREAM | 15 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-554 | KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 2 package rows | 20110121_836ebf14-fb11-45c3-9e0c-db1bebcd0f5b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-554-15 | 21695055415 | 1 in 1 CARTON | Historical |