Fluconazole
- Product NDC
- 68071-2557
- 11-digit product format
- 680712557
- Labeler code
- 68071
- Product ID
- 68071-2557_2dcc5468-9b13-b6d5-e063-6294a90a4139
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA077253
- Marketing category
- ANDA
- Marketing start
- 2020-11-20
- Substance
- FLUCONAZOLE
- Active strength
- 150 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 |
|---|
| 68071-2557-1 | 68071255701 | 12 BLISTER PACK in 1 CARTON (68071-2557-1) / 1 TABLET in 1 BLISTER PACK | 12 blister pack | 2021-10-28 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluconazole Tablets | NuCare Pharmaceuticals,Inc. | 2025-02-10 | HUMAN PRESCRIPTION DRUG LABEL | 4 |