Fluconazole
- Product NDC
- 0338-6046
- 11-digit product format
- 003386046
- Labeler code
- 0338
- Product ID
- 0338-6046_36e35cdf-c4a0-428a-879e-1d65e2b66f64
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Baxter Healthcare Company
- Application
- ANDA076766
- Marketing category
- ANDA
- Marketing start
- 2004-07-29
- Substance
- FLUCONAZOLE
- Active strength
- 200 mg/100mL
- 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 | 200 mg/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8VZV102JFY |
| Rxcui | 1721314, 1721315 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0338-6046-48 | Fluconazole | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | | 27 |
| 0338-6046-48 | Fluconazole | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 27 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0338-6046 | FLUCONAZOLE INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY] | 26 | Current NDC, Legacy NDC, 2 package rows | 20250507_cd24a261-9c15-42b4-8040-89d2dbda174e.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 |
|---|
| 0338-6046-48 | 00338604648 | 10 BAG in 1 CARTON (0338-6046-48) / 100 mL in 1 BAG | 10 bag | 2004-07-29 | 0000-00-00 | No | No | Current |