Fluconazole
- Product NDC
- 55289-824
- 11-digit product format
- 552890824
- Labeler code
- 55289
- Product ID
- 55289-824_2ac0449d-f1fd-33f4-e063-6394a90a9402
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA077253
- Marketing category
- ANDA
- Marketing start
- 2006-01-25
- Substance
- FLUCONAZOLE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 8VZV102JFY | FLUCONAZOLE | 86386-73-4 | FLUCONAZOLE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55289-824-20 | 55289082420 | 20 TABLET in 1 BOTTLE, PLASTIC (55289-824-20) | 20 tablet | 2011-05-20 | No | No | Historical |
| 55289-824-30 | 55289082430 | 30 TABLET in 1 BOTTLE, PLASTIC (55289-824-30) | 30 tablet | 2011-05-20 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluconazole Tablets | PD-Rx Pharmaceuticals, Inc. | 2025-01-02 | HUMAN PRESCRIPTION DRUG LABEL | 31 |