Fluconazole
- Product NDC
- 65862-299
- 11-digit product format
- 658620299
- Labeler code
- 65862
- Product ID
- 65862-299_5305f9a9-119f-43e6-a48a-1598094d6c8f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA079150
- Marketing category
- ANDA
- Marketing start
- 2009-09-18
- Substance
- FLUCONAZOLE
- Active strength
- 10 mg/mL
- 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 |
|---|
| 65862-299-35 | 65862029935 | 1 BOTTLE in 1 CARTON (65862-299-35) / 35 mL in 1 BOTTLE | 1 bottle | 2009-09-18 | No | No | Historical |