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NDC 65862-0299-35 Fluconazole 10 mg/mL Details
Fluconazole 10 mg/mL
Fluconazole is a ORAL POWDER, FOR SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is FLUCONAZOLE.
MedlinePlus Drug Summary
Fluconazole is used to treat fungal infections, including yeast infections of the vagina, 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: 65862-0299-35Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fluconazole
Product Information
| NDC | 65862-0299 |
|---|---|
| Product ID | 65862-299_e5dde38e-1ec2-4091-8585-9c55be4e1d5d |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Fluconazole |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fluconazole |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | POWDER, FOR SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/mL |
| Substance Name | FLUCONAZOLE |
| Labeler Name | Aurobindo Pharma Limited |
| 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 | ANDA079150 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65862-0299-35 (65862029935)
| NDC Package Code | 65862-299-35 |
|---|---|
| Billing NDC | 65862029935 |
| Package | 1 BOTTLE in 1 CARTON (65862-299-35) / 35 mL in 1 BOTTLE |
| Marketing Start Date | 2009-09-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |