ABELCET
ABELCET® (Amphotericin B Lipid Complex Injection) 100 mg
Approved
Approval ID
5587db37-f21a-4a39-a319-e1077032ced9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 21, 2023
Manufacturers
FDA
Leadiant Biosciences, Inc.
DUNS: 068301431
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
amphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl-
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57665-101
Application NumberNDA050724
Product Classification
M
Marketing Category
C73594
G
Generic Name
amphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl-
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 21, 2023
FDA Product Classification
INGREDIENTS (5)
AMPHOTERICIN BActive
Quantity: 5 mg in 1 mL
Code: 7XU7A7DROE
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-Active
Quantity: 3.4 mg in 1 mL
Code: U86ZGC74V5
Classification: ACTIB
DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-Active
Quantity: 1.5 mg in 1 mL
Code: BI71WT9P3R
Classification: ACTIB