Search by Drug Name or NDC
NDC 57665-0101-41 ABELCET 5; 3.4; 1.5 mg/mL; mg/mL; mg/mL Details
ABELCET 5; 3.4; 1.5 mg/mL; mg/mL; mg/mL
ABELCET is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Leadiant Biosciences, Inc.. The primary component is AMPHOTERICIN B; DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-; DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-.
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: 57665-0101-41Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Amphotericin B Injection
Product Information
| NDC | 57665-0101 |
|---|---|
| Product ID | 57665-101_0aab355d-bbe3-5a46-e063-6294a90a971f |
| Associated GPIs | 11000010301820 |
| GCN Sequence Number | 024440 |
| GCN Sequence Number Description | amphotericin B lipid complex VIAL 5 MG/ML INTRAVEN |
| HIC3 | W3A |
| HIC3 Description | ANTIFUNGAL ANTIBIOTICS |
| GCN | 07382 |
| HICL Sequence Number | 010219 |
| HICL Sequence Number Description | AMPHOTERICIN B LIPID COMPLEX |
| Brand/Generic | Brand |
| Proprietary Name | ABELCET |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | amphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl- |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 5; 3.4; 1.5 |
| Active Ingredient Units | mg/mL; mg/mL; mg/mL |
| Substance Name | AMPHOTERICIN B; DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-; DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- |
| Labeler Name | Leadiant Biosciences, Inc. |
| Pharmaceutical Class | Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA050724 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 57665-0101-41 (57665010141)
| NDC Package Code | 57665-101-41 |
|---|---|
| Billing NDC | 57665010141 |
| Package | 1 VIAL in 1 CARTON (57665-101-41) / 20 mL in 1 VIAL |
| Marketing Start Date | 2010-10-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |