Ketoconazole
- Product NDC
- 68071-1709
- 11-digit product format
- 680711709
- Labeler code
- 68071
- Product ID
- 68071-1709_2a321ff6-d67f-0fca-e063-6394a90a8644
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA075638
- Marketing category
- ANDA
- Marketing start
- 2002-12-18
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-1709-3 | Ketoconazole | 30 g in 1 BOX | CREAM | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-1709 | KETOCONAZOLE CREAM [NUCARE PHARMACEUTICALS,INC.] | 6 | Current NDC, Legacy NDC, 1 package rows | 20241228_570acb82-0c6f-0b98-e054-00144ff8d46c.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 |
|---|
| 68071-1709-3 | 68071170903 | 30 g in 1 BOX (68071-1709-3) | 30 g | 2017-08-18 | 0000-00-00 | No | No | Current |