Fluconazole
- Product NDC
- 62559-991
- 11-digit product format
- 625590991
- Labeler code
- 62559
- Product ID
- 62559-991_eec2c521-a32a-482b-afb4-057860a109cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA078423
- Marketing category
- ANDA
- Marketing start
- 2021-04-22
- 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 |
|---|
| 62559-991-30 | Fluconazole | 30 in 1 BOTTLE | TABLET | 30 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62559-991 | FLUCONAZOLE TABLET [ANI PHARMACEUTICALS, INC.] | 11 | Current NDC, Legacy NDC, 1 package rows | 20240920_8f90f169-6a72-4c33-a2af-0bc943602bc2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62559-991-30 | 62559099130 | 30 TABLET in 1 BOTTLE (62559-991-30) | 30 tablet | 2021-04-22 | 0000-00-00 | No | No | Current |