Fluconazole
- Product NDC
- 67405-601
- 11-digit product format
- 674050601
- Labeler code
- 67405
- Product ID
- 67405-601_47d7831b-686a-4a1e-909c-db15efb8252d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Harris Pharmaceutical, Inc.
- Application
- ANDA078423
- Marketing category
- ANDA
- Marketing start
- 2011-03-07
- Marketing end
- 2023-07-31
- Substance
- FLUCONAZOLE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67405-601-03 | 67405060103 | 30 TABLET in 1 BOTTLE (67405-601-03) | 30 tablet | 2015-08-10 | 2023-07-31 | No | No | Current |