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NDC 55150-0388-01 POSACONAZOLE 18 mg/mL Details
POSACONAZOLE 18 mg/mL
POSACONAZOLE is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Eugia US LLC. The primary component is POSACONAZOLE.
MedlinePlus Drug Summary
Posaconazole injection is used to prevent serious fungal infections that can spread throughout the body in adults and children 2 years of age and older with a weakened ability to fight infection. Posaconazole injection is also used to treat invasive aspergillosis (a serious fungal infection that begins in the lungs and spreads through the bloodstream to other organs) in adults and teenagers 13 years of age and older. Posaconazole injection is in a class of medications called azole antifungals. It works by slowing the growth of fungi that cause infection.
Related Packages: 55150-0388-01Last Updated: 04/21/2024
MedLinePlus Full Drug Details: Posaconazole Injection
Product Information
| NDC | 55150-0388 |
|---|---|
| Product ID | 55150-388_2e88e379-b712-4dec-97a2-c90ef3638372 |
| Associated GPIs | |
| GCN Sequence Number | 072141 |
| GCN Sequence Number Description | posaconazole VIAL 300MG/16.7 INTRAVEN |
| HIC3 | W3B |
| HIC3 Description | ANTIFUNGAL AGENTS |
| GCN | 36248 |
| HICL Sequence Number | 033461 |
| HICL Sequence Number Description | POSACONAZOLE |
| Brand/Generic | Generic |
| Proprietary Name | POSACONAZOLE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | POSACONAZOLE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 18 |
| Active Ingredient Units | mg/mL |
| Substance Name | POSACONAZOLE |
| Labeler Name | Eugia US LLC |
| Pharmaceutical Class | Azole Antifungal [EPC], Azoles [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA214842 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 55150-0388-01 (55150038801)
| NDC Package Code | 55150-388-01 |
|---|---|
| Billing NDC | 55150038801 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-388-01) / 16.7 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2023-12-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |