Ketoconazole
- Product NDC
- 68071-1614
- 11-digit product format
- 680711614
- Labeler code
- 68071
- Product ID
- 68071-1614_bb121b51-beb8-7343-e053-2995a90aed1b
- 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
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-1614-5 | 68071161405 | 15 g in 1 BOX (68071-1614-5) | 15 g | 2017-09-05 | 0000-00-00 | No | No | Current |