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NDC 00338-6045-37 Fluconazole 400 mg/200mL Details
Fluconazole 400 mg/200mL
Fluconazole is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is FLUCONAZOLE.
MedlinePlus Drug Summary
Fluconazole injection is used to treat fungal infections, including yeast infections of the mouth, throat, esophagus (tube leading from the mouth to the stomach), abdomen (area between the chest and waist), lungs, blood, and other organs. Fluconazole is also used to treat meningitis (infection of the membranes covering the brain and spine) caused by fungus. Fluconazole is also used to prevent yeast infections in patients who are likely to become infected because they are being treated with chemotherapy or radiation therapy before a bone marrow transplant (replacement of unhealthy spongy tissue inside the bones with healthy tissue). Fluconazole is in a class of antifungals called triazoles. It works by slowing the growth of fungi that cause infection.
Related Packages: 00338-6045-37Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluconazole Injection
Product Information
| NDC | 00338-6045 |
|---|---|
| Product ID | 0338-6045_3d6857d5-f305-48d0-95bf-442a3cb8fd45 |
| Associated GPIs | 11407015012020 |
| GCN Sequence Number | 015331 |
| GCN Sequence Number Description | fluconazole in NaCL,iso-osm PIGGYBACK 400MG/0.2L INTRAVEN |
| HIC3 | W3B |
| HIC3 Description | ANTIFUNGAL AGENTS |
| GCN | 69791 |
| HICL Sequence Number | 034344 |
| HICL Sequence Number Description | FLUCONAZOLE IN SODIUM CHLORIDE, ISO-OSMOTIC |
| Brand/Generic | Generic |
| Proprietary Name | Fluconazole |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fluconazole |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 400 |
| Active Ingredient Units | mg/200mL |
| Substance Name | FLUCONAZOLE |
| Labeler Name | Baxter Healthcare Corporation |
| Pharmaceutical Class | Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076766 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00338-6045-37 (00338604537)
| NDC Package Code | 0338-6045-37 |
|---|---|
| Billing NDC | 00338604537 |
| Package | 10 BAG in 1 CARTON (0338-6045-37) / 200 mL in 1 BAG |
| Marketing Start Date | 2004-07-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |