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NDC 00469-2860-35 CRESEMBA 40 mg/1 Details
CRESEMBA 40 mg/1
CRESEMBA is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Astellas Pharma US, Inc.. The primary component is ISAVUCONAZONIUM SULFATE.
MedlinePlus Drug Summary
Isavuconazonium is used 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) and invasive mucormycosis (a fungal infection that usually begins in the sinuses, brain, or lungs). Isavuconazonium is in a class of medications called azole antifungals. It works by slowing the growth of fungi that cause infection.
Related Packages: 00469-2860-35Last Updated: 02/05/2023
MedLinePlus Full Drug Details: Isavuconazonium
Product Information
| NDC | 00469-2860 |
|---|---|
| Product ID | 0469-2860_a91d60a8-2fa7-4f5c-b10b-852309428863 |
| Associated GPIs | |
| GCN Sequence Number | 085265 |
| GCN Sequence Number Description | isavuconazonium sulfate CAPSULE 74.5 MG ORAL |
| HIC3 | W3B |
| HIC3 Description | ANTIFUNGAL AGENTS |
| GCN | 54696 |
| HICL Sequence Number | 041817 |
| HICL Sequence Number Description | ISAVUCONAZONIUM SULFATE |
| Brand/Generic | Brand |
| Proprietary Name | CRESEMBA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | isavuconazonium sulfate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 40 |
| Active Ingredient Units | mg/1 |
| Substance Name | ISAVUCONAZONIUM SULFATE |
| Labeler Name | Astellas Pharma US, Inc. |
| Pharmaceutical Class | Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA207500 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00469-2860-35 (00469286035)
| NDC Package Code | 0469-2860-35 |
|---|---|
| Billing NDC | 00469286035 |
| Package | 35 BLISTER PACK in 1 CARTON (0469-2860-35) / 1 CAPSULE in 1 BLISTER PACK |
| Marketing Start Date | 2022-11-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |