Ketoconazole
- Product NDC
- 68071-1735
- 11-digit product format
- 680711735
- Labeler code
- 68071
- Product ID
- 68071-1735_bb17da97-c264-3443-e053-2995a90a3bb3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- SHAMPOO, SUSPENSION
- Route
- TOPICAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA076942
- Marketing category
- ANDA
- Marketing start
- 2016-10-01
- Marketing end
- 0000-00-00
- Substance
- KETOCONAZOLE
- Active strength
- 21 mg/mL
- 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
- 2022-12-31
- 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 |
|---|
| 68071-1735-4 | Ketoconazole | 120 mL in 1 BOTTLE | SHAMPOO, SUSPENSION | 120 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-1735 | KETOCONAZOLE SHAMPOO, SUSPENSION [NUCARE PHARMACEUTICALS,INC.] | 4 | Legacy NDC, 1 package rows | 20210212_54c69554-0b09-27e7-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 |
|---|
| 68071-1735-4 | 68071173504 | 120 mL in 1 BOTTLE (68071-1735-4) | 120 ml | 2017-07-20 | 0000-00-00 | No | No | Current |