Fluconazole
- Product NDC
- 77771-397
- 11-digit product format
- 777710397
- Labeler code
- 77771
- Product ID
- 77771-397_4616cc03-ba84-a659-e063-6294a90a7dcb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Radha Pharmaceuticals Inc
- Application
- ANDA077253
- Marketing category
- ANDA
- Marketing start
- 2025-12-10
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluconazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUCONAZOLE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8VZV102JFY |
| Rxcui | 197698, 197699, 197700, 197701 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 77771-397-01 | Fluconazole | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 77771-397-30 | Fluconazole | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 77771-397-01 | 77771039701 | 100 TABLET in 1 BOTTLE (77771-397-01) | 100 tablet | 2025-12-10 | No | No | Current |
| 77771-397-30 | 77771039730 | 30 TABLET in 1 BOTTLE (77771-397-30) | 30 tablet | 2025-12-10 | No | No | Current |