Ketoconazole
- Product NDC
- 68071-2309
- 11-digit product format
- 680712309
- Labeler code
- 68071
- Product ID
- 68071-2309_d59062ee-e443-022f-e053-2a95a90a7d20
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA075581
- Marketing category
- ANDA
- Marketing start
- 2019-02-08
- 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
- 2023-12-31
- 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 |
|---|
| 68071-2309-3 | Ketoconazole | 1 in 1 CARTON | CREAM | 1 | | 2 |
| 68071-2309-3 | Ketoconazole | 30 g in 1 TUBE | CREAM | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-2309 | KETOCONAZOLE CREAM [NUCARE PHARMACEUTICALS,INC.] | 2 | Legacy NDC, 2 package rows | 20220115_b5e3da2b-940d-eac1-e053-2995a90a6058.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 |
|---|
| 68071-2309-3 | 68071230903 | 1 TUBE in 1 CARTON (68071-2309-3) > 30 g in 1 TUBE | 1 tube | 2020-12-07 | 0000-00-00 | No | No | Current |