NDC 57665-101

ABELCET

Amphotericin B, Dimyristoylphosphatidylcholine, Dl- And Dimyristoylphosphatidylglycerol, Dl-

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-.

• Product ID: 57665-101_6ecda967-3197-42b0-8ee5-4541a78866a7
• NDC: 57665-101
• Product Type: Human Prescription Drug
• Proprietary Name: ABELCET
• Generic Name: Amphotericin B, Dimyristoylphosphatidylcholine, Dl- And Dimyristoylphosphatidylglycerol, Dl-
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2010-10-18
• Marketing Category: NDA / NDA
• Application Number: NDA050724
• Labeler Name: Leadiant Biosciences, Inc.
• Substance Name: AMPHOTERICIN B; DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-; DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-
• Active Ingredient Strength: 5 mg/mL; mg/mL; mg/mL
• Pharm Classes: Lipid-based Polyene Antifungal [EPC],Polyene Antifungal [EPC],Polyenes [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 57665-101-41

1 VIAL in 1 CARTON (57665-101-41) > 20 mL in 1 VIAL

• Marketing Start Date: 2010-10-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57665-101-41 [57665010141]

ABELCET INJECTION

• Marketing Category: NDA
• Application Number: NDA050724
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-10-18

Drug Details

Active Ingredients

Ingredient	Strength
AMPHOTERICIN B	5 mg/mL

OpenFDA Data

• SPL SET ID: 5587db37-f21a-4a39-a319-e1077032ced9
• Manufacturer:
  • Leadiant Biosciences, Inc.
• UNII:
  • 7XU7A7DROE
  • BI71WT9P3R
  • U86ZGC74V5
• RxNorm Concept Unique ID - RxCUI:
  • 984078
  • 984082

Pharmacological Class

• Lipid-based Polyene Antifungal [EPC]
• Polyene Antifungal [EPC]
• Polyenes [CS]