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NDC 65862-0891-01 Voriconazole 50 mg/1 Details
Voriconazole 50 mg/1
Voriconazole is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is VORICONAZOLE.
MedlinePlus Drug Summary
Voriconazole is used in adults and children 2 years of age and older to treat serious fungal infections such as invasive aspergillosis (a fungal infection that begins in the lungs and spreads through the bloodstream to other organs), esophageal candidiasis (a yeast [a type of fungus] infection that may cause white patching in the mouth and throat), and candidemia (a fungal infection in the blood). It is also used to treat certain other fungal infections when other medications will not work for certain patients. Voriconazole is in a class of antifungal medications called triazoles. It works by slowing the growth of the fungi that cause infection.
Related Packages: 65862-0891-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Voriconazole
Product Information
| NDC | 65862-0891 |
|---|---|
| Product ID | 65862-891_aa0c1770-e92f-453b-b07f-f28d28fc092b |
| Associated GPIs | 11407080000320 |
| GCN Sequence Number | 050442 |
| GCN Sequence Number Description | voriconazole TABLET 50 MG ORAL |
| HIC3 | W3B |
| HIC3 Description | ANTIFUNGAL AGENTS |
| GCN | 17497 |
| HICL Sequence Number | 023720 |
| HICL Sequence Number Description | VORICONAZOLE |
| Brand/Generic | Generic |
| Proprietary Name | Voriconazole |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Voriconazole |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/1 |
| Substance Name | VORICONAZOLE |
| 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 | ANDA206837 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65862-0891-01 (65862089101)
| NDC Package Code | 65862-891-01 |
|---|---|
| Billing NDC | 65862089101 |
| Package | 100 TABLET, FILM COATED in 1 BOTTLE (65862-891-01) |
| Marketing Start Date | 2016-01-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |