Fluconazole
- Product NDC
- 57237-003
- 11-digit product format
- 572370003
- Labeler code
- 57237
- Product ID
- 57237-003_1018b9ad-7145-49b4-903a-b483797d7c86
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA077731
- Marketing category
- ANDA
- Marketing start
- 2008-10-07
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluconazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUCONAZOLE | 50 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 |
|---|
| 57237-003-30 | Fluconazole | 30 in 1 BOTTLE | TABLET | 30 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57237-003 | FLUCONAZOLE TABLET [RISING PHARMA HOLDINGS, INC.] | 17 | Current NDC, Legacy NDC, 1 package rows | 20240822_2ca7efcd-4a8d-4139-a3eb-930afd18b13f.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 |
|---|
| 57237-003-30 | 57237000330 | 30 TABLET in 1 BOTTLE (57237-003-30) | 30 tablet | 2008-10-07 | 0000-00-00 | No | No | Current |