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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

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ABELCET - FDA Drug Approval Details