Fluconazole
- Product NDC
- 57237-149
- 11-digit product format
- 572370149
- Labeler code
- 57237
- Product ID
- 57237-149_8c4429e6-5542-4bec-9d50-1021ea548c01
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA079150
- Marketing category
- ANDA
- Marketing start
- 2009-09-18
- Substance
- FLUCONAZOLE
- Active strength
- 10 mg/mL
- 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 | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8VZV102JFY |
| Rxcui | 310352, 310353 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57237-149-35 | Fluconazole | 35 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 35 | | 16 |
| 57237-149-35 | Fluconazole | 1 in 1 CARTON | POWDER, FOR SUSPENSION | 1 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57237-149 | FLUCONAZOLE POWDER, FOR SUSPENSION [RISING PHARMA HOLDINGS, INC.] | 16 | Current NDC, Legacy NDC, 2 package rows | 20240827_ccbe0991-27a1-4ddb-bfc7-1b3422e53390.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 |
|---|
| 57237-149-35 | 57237014935 | 1 BOTTLE in 1 CARTON (57237-149-35) / 35 mL in 1 BOTTLE | 1 bottle | 2009-09-18 | 0000-00-00 | No | No | Current |