Fluconazole
- Product NDC
- 63629-8970
- 11-digit product format
- 636298970
- Labeler code
- 63629
- Product ID
- 63629-8970_f0a93e29-d92a-4f5c-835c-5cfd2e134f8d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078423
- Marketing category
- ANDA
- Marketing start
- 2021-04-22
- Substance
- FLUCONAZOLE
- Active strength
- 50 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 |
|---|
| 63629-8970-1 | 63629897001 | 30 TABLET in 1 BOTTLE (63629-8970-1) | 30 tablet | 2024-10-08 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Fluconazole Tablets USP | Bryant Ranch Prepack | 2024-10-08 | HUMAN PRESCRIPTION DRUG LABEL | 104 |