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NDC 00469-3051-30 AmBisome 50 mg/12.5mL Details
AmBisome 50 mg/12.5mL
AmBisome is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Astellas Pharma US, Inc.. The primary component is AMPHOTERICIN B.
MedlinePlus Drug Summary
Amphotericin B injection is used to treat serious and potentially life-threatening fungal infections. Amphotericin B injection is in a class of medications called antifungals. It works by slowing the growth of fungi that cause infection.
Related Packages: 00469-3051-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Amphotericin B Injection
Product Information
| NDC | 00469-3051 |
|---|---|
| Product ID | 0469-3051_26d0ac07-3801-4595-86e6-f14f1435b82f |
| Associated GPIs | 11000010401920 |
| GCN Sequence Number | 030773 |
| GCN Sequence Number Description | amphotericin B liposome VIAL 50 MG INTRAVEN |
| HIC3 | W3A |
| HIC3 Description | ANTIFUNGAL ANTIBIOTICS |
| GCN | 07387 |
| HICL Sequence Number | 012800 |
| HICL Sequence Number Description | AMPHOTERICIN B LIPOSOME |
| Brand/Generic | Brand |
| Proprietary Name | AmBisome |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | amphotericin B |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/12.5mL |
| Substance Name | AMPHOTERICIN B |
| Labeler Name | Astellas Pharma US, Inc. |
| Pharmaceutical Class | Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA050740 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00469-3051-30 (00469305130)
| NDC Package Code | 0469-3051-30 |
|---|---|
| Billing NDC | 00469305130 |
| Package | 12.5 mL in 1 VIAL, SINGLE-DOSE (0469-3051-30) |
| Marketing Start Date | 1997-08-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |