Fluconazole
- Product NDC
- 71205-650
- 11-digit product format
- 712050650
- Labeler code
- 71205
- Product ID
- 71205-650_2e7093ee-60d8-4b7f-b28d-f415a36ae086
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA078423
- Marketing category
- ANDA
- Marketing start
- 2021-04-22
- 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 |
|---|
| 71205-650-03 | 71205065003 | 3 TABLET in 1 BOTTLE (71205-650-03) | 3 tablet | 2023-02-09 | No | No | Historical |
| 71205-650-10 | 71205065010 | 10 TABLET in 1 BOTTLE (71205-650-10) | 10 tablet | 2022-03-29 | No | No | Historical |
| 71205-650-20 | 71205065020 | 20 TABLET in 1 BOTTLE (71205-650-20) | 20 tablet | 2022-03-29 | No | No | Historical |
| 71205-650-30 | 71205065030 | 30 TABLET in 1 BOTTLE (71205-650-30) | 30 tablet | 2022-03-29 | No | No | Historical |
| 71205-650-60 | 71205065060 | 60 TABLET in 1 BOTTLE (71205-650-60) | 60 tablet | 2022-03-29 | No | No | Historical |
| 71205-650-90 | 71205065090 | 90 TABLET in 1 BOTTLE (71205-650-90) | 90 tablet | 2022-03-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluconazole Tablets USP | Proficient Rx LP | 2023-02-01 | HUMAN PRESCRIPTION DRUG LABEL | 2 |