Fluconazole
- Product NDC
- 82804-218
- 11-digit product format
- 828040218
- Labeler code
- 82804
- Product ID
- 82804-218_c0193e27-f1a4-4698-a6bb-3df772c16256
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA077253
- Marketing category
- ANDA
- Marketing start
- 2006-01-25
- Substance
- FLUCONAZOLE
- Active strength
- 100 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 |
|---|
| 82804-218-03 | 82804021803 | 3 TABLET in 1 BOTTLE (82804-218-03) | 3 tablet | 2025-04-21 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluconazole Tablets | Proficient Rx LP | 2025-04-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |