Ketoconazole
- Product NDC
- 71085-008
- 11-digit product format
- 710850008
- Labeler code
- 71085
- Product ID
- 71085-008_ea618ceb-2b37-4885-a3da-16bbf0fa429a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- IPG 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71085-008 | KETOCONAZOLE CREAM [IPG PHARMACEUTICALS, INC.] | 1 | Legacy NDC | 20170218_51363e79-8681-4b68-aebf-09323c95809b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71085-008-60 | 71085000860 | 1 TUBE in 1 CARTON (71085-008-60) > 60 g in 1 TUBE | 1 tube | 2016-12-21 | 0000-00-00 | No | No | Current |