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NDC 50458-0290-01 SPORANOX 100 mg/1 Details
SPORANOX 100 mg/1
SPORANOX is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. 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: 50458-0290-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Itraconazole
Product Information
| NDC | 50458-0290 |
|---|---|
| Product ID | 50458-290_091c35a0-b034-20e9-e063-6294a90a99f5 |
| Associated GPIs | 11407035000120 |
| GCN Sequence Number | 016949 |
| GCN Sequence Number Description | itraconazole CAPSULE 100 MG ORAL |
| HIC3 | W3B |
| HIC3 Description | ANTIFUNGAL AGENTS |
| GCN | 49101 |
| HICL Sequence Number | 006503 |
| HICL Sequence Number Description | ITRACONAZOLE |
| Brand/Generic | Brand |
| Proprietary Name | SPORANOX |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ITRACONAZOLE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | ITRACONAZOLE |
| Labeler Name | Janssen Pharmaceuticals, Inc. |
| 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 | NDA |
| Application Number | NDA020083 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50458-0290-01 (50458029001)
| NDC Package Code | 50458-290-01 |
|---|---|
| Billing NDC | 50458029001 |
| Package | 3 BLISTER PACK in 1 CARTON (50458-290-01) / 10 CAPSULE in 1 BLISTER PACK |
| Marketing Start Date | 1992-09-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |