Fluconazole
- Product NDC
- 70518-4413
- 11-digit product format
- 705184413
- Labeler code
- 70518
- Product ID
- 70518-4413_3b8a60b9-c016-1801-e063-6294a90a5bb3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA077253
- Marketing category
- ANDA
- Marketing start
- 2025-07-31
- 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 |
|---|
| 70518-4413-0 | 70518441300 | 30 TABLET in 1 BLISTER PACK (70518-4413-0) | 30 tablet | 2025-07-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluconazole Tablets | REMEDYREPACK INC. | 2025-08-04 | HUMAN PRESCRIPTION DRUG LABEL | 1 |