FDA.reportPublic FDA data

ABELCET

Product NDC
57665-101
11-digit product format
576650101
Labeler code
57665
Product ID
57665-101_ef1a50cb-a1a1-2602-e053-2a95a90a0e4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl-
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Leadiant Biosciences, Inc.
Application
NDA050724
Marketing category
NDA
Marketing start
2010-10-18
Marketing end
0000-00-00
Substance
AMPHOTERICIN B; DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-; DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-
Active strength
5 mg/mL; mg/mL; mg/mL
Pharmacologic classes
Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57665-101DDiscontinued by firm2026-07-31
excluded packagepackage57665-10157665-101-41DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050724-001ABELCETAMPHOTERICIN B5MG/MLINJECTABLE, LIPID COMPLEX / INJECTIONRLD1995-11-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N050724-001ABELCET5MG/MLINJECTABLE, LIPID COMPLEX / INJECTIONRLD1995-11-20a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57665-101-41ML - Milliliter57665-1010dc579f4-7c58-4a62-93b8-5610ac136f2412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMPHOTERICIN BACTIVE INGREDIENT7XU7A7DROEABELCET (AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-) INJECTION [SIGMA-TAU PHARMACEUTICALS, INC.]5
DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-ACTIVE INGREDIENTU86ZGC74V5ABELCET (AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-) INJECTION [SIGMA-TAU PHARMACEUTICALS, INC.]5
DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-ACTIVE INGREDIENTBI71WT9P3RABELCET (AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-) INJECTION [SIGMA-TAU PHARMACEUTICALS, INC.]5
AMPHOTERICIN BACTIVE MOIETY7XU7A7DROEABELCET (AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-) INJECTION [SIGMA-TAU PHARMACEUTICALS, INC.]5
DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-ACTIVE MOIETYU86ZGC74V5ABELCET (AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-) INJECTION [SIGMA-TAU PHARMACEUTICALS, INC.]5
DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-ACTIVE MOIETYBI71WT9P3RABELCET (AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-) INJECTION [SIGMA-TAU PHARMACEUTICALS, INC.]5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XABELCET (AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-) INJECTION [SIGMA-TAU PHARMACEUTICALS, INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RABELCET (AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-) INJECTION [SIGMA-TAU PHARMACEUTICALS, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57665-101ABELCET (AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-) INJECTION [LEADIANT BIOSCIENCES, INC.]15Legacy NDC20231122_5587db37-f21a-4a39-a319-e1077032ced9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57665-101-41576650101411 VIAL in 1 CARTON (57665-101-41) > 20 mL in 1 VIAL1 vial2010-10-180000-00-00NoNoCurrent