Fluconazole
- Product NDC
- 85766-103
- 11-digit product format
- 857660103
- Labeler code
- 85766
- Product ID
- 85766-103_5031f501-a03c-c192-e063-6294a90ae96c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sportpharm LLC
- Application
- ANDA076658
- Marketing category
- ANDA
- Marketing start
- 2014-06-20
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluconazole
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUCONAZOLE | 150 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 |
|---|
| 85766-103-12 | Fluconazole | 12 in 1 CARTON | TABLET | 12 | | 2 |
| 85766-103-12 | Fluconazole | 1 in 1 DOSE PACK | TABLET | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85766-103-12 | 85766010312 | 12 DOSE PACK in 1 CARTON (85766-103-12) / 1 TABLET in 1 DOSE PACK | 12 dose pack | 2025-10-10 | No | No | Historical |