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NDC 65162-0087-34 Itraconazole 10 mg/mL Details
Itraconazole 10 mg/mL
Itraconazole is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is ITRACONAZOLE.
MedlinePlus Drug Summary
Itraconazole capsules are used to treat fungal infections in the lungs that can spread throughout the body. Itraconazole capsules are also used to treat fungal infections of the fingernails. Itraconazole tablets and capsules are used to treat fungal infections of the toenails. Itraconazole oral solution (liquid) is used to treat yeast infections of the mouth and throat or of the esophagus (tube that connects the throat to the stomach). Itraconazole is in a class of antifungals called triazoles. It works by slowing the growth of fungi that cause infection.
Related Packages: 65162-0087-34Last Updated: 02/19/2023
MedLinePlus Full Drug Details: Itraconazole
Product Information
| NDC | 65162-0087 |
|---|---|
| Product ID | 65162-087_6166e314-4a3d-4574-a7e1-ddb94c91f473 |
| Associated GPIs | 11407035002020 |
| GCN Sequence Number | 027465 |
| GCN Sequence Number Description | itraconazole SOLUTION 10 MG/ML ORAL |
| HIC3 | W3B |
| HIC3 Description | ANTIFUNGAL AGENTS |
| GCN | 49100 |
| HICL Sequence Number | 006503 |
| HICL Sequence Number Description | ITRACONAZOLE |
| Brand/Generic | Generic |
| Proprietary Name | Itraconazole |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Itraconazole |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/mL |
| Substance Name | ITRACONAZOLE |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA205573 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 65162-0087-34 (65162008734)
| NDC Package Code | 65162-087-34 |
|---|---|
| Billing NDC | 65162008734 |
| Package | 10 CUP, UNIT-DOSE in 1 TRAY (65162-087-34) / 10 mL in 1 CUP, UNIT-DOSE (65162-087-13) |
| Marketing Start Date | 2014-04-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |