Ketoconazole
- Product NDC
- 68788-9117
- 11-digit product format
- 687889117
- Labeler code
- 68788
- Product ID
- 68788-9117_7f77064a-3ee3-49dc-bf91-69010c7217b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA075273
- Marketing category
- ANDA
- Marketing start
- 2011-05-31
- Marketing end
- 0000-00-00
- Substance
- KETOCONAZOLE
- Active strength
- 200 mg/1
- 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68788-9117-1 | 2020-11-12 | C162847 | 48780-1 | 9d75b9d0-62ce-f424-e053-dadaa90a57ce | be3eb758-2659-4f8b-abb7-cc57740e7331 |
| 68788-9117-3 | 2020-11-12 | C162847 | 48780-1 | 9d75b9d0-62ce-f424-e053-dadaa90a57ce | be3eb758-2659-4f8b-abb7-cc57740e7331 |
| 68788-9117-6 | 2020-11-12 | C162847 | 48780-1 | 9d75b9d0-62ce-f424-e053-dadaa90a57ce | be3eb758-2659-4f8b-abb7-cc57740e7331 |
| 68788-9117-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-62ce-f424-e053-dadaa90a57ce | be3eb758-2659-4f8b-abb7-cc57740e7331 |
| 68788-9117-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-62ce-f424-e053-dadaa90a57ce | be3eb758-2659-4f8b-abb7-cc57740e7331 |
| 68788-9117-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-62ce-f424-e053-dadaa90a57ce | be3eb758-2659-4f8b-abb7-cc57740e7331 |