FLUCONAZOLE
- Product NDC
- 76420-587
- 11-digit product format
- 764200587
- Labeler code
- 76420
- Product ID
- 76420-587_044738e8-265d-d820-e063-6394a90a9e68
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FLUCONAZOLE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA076665
- Marketing category
- ANDA
- Marketing start
- 2004-07-29
- 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
- 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 | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8VZV102JFY |
| Rxcui | 197699 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-587-01 | FLUCONAZOLE | 1 in 1 BOTTLE | TABLET | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-587 | FLUCONAZOLE TABLET [ASCLEMED USA, INC.] | 1 | Current NDC, 1 package rows | 20230902_3208dc64-6117-4b2d-9008-76a819cef7d7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-587-01 | 76420058701 | 1 TABLET in 1 BOTTLE (76420-587-01) | 1 tablet | 2023-09-01 | No | No | Historical |