FDA.reportPublic FDA data

NDC 0024-5154 - Elitek

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0024-5154
Package NDCs from labels
0024-5154-11
Manufacturer
Sanofi-Aventis U.S. LLC | Sanofi Winthrop Industrie | Sanofi S.r.l.
Effective date
2025-05-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Elitek - Sanofi-Aventis U.S. LLC | Sanofi Winthrop Industrie | Sanofi S.r.l.Sanofi-Aventis U.S. LLC | Sanofi Winthrop Industrie | Sanofi S.r.l.2025-05-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0024-5154-11Elitek1 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,1 mL1.5 mg in 1mL23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-5154ELITEK (RASBURICASE) KIT [SANOFI-AVENTIS U.S. LLC]23Unmatched20250515_0ae10bc4-6b65-402f-9db5-2d7753054922.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
rasburicaseACTIVE INGREDIENT08GY9K1EUOELITEK (RASBURICASE) KIT [SANOFI-AVENTIS U.S. LLC]10
rasburicaseACTIVE MOIETY08GY9K1EUOELITEK (RASBURICASE) KIT [SANOFI-AVENTIS U.S. LLC]10
alanineINACTIVE INGREDIENTOF5P57N2ZXELITEK (RASBURICASE) KIT [SANOFI-AVENTIS U.S. LLC]10
mannitolINACTIVE INGREDIENT3OWL53L36AELITEK (RASBURICASE) KIT [SANOFI-AVENTIS U.S. LLC]10
poloxamer 188INACTIVE INGREDIENTLQA7B6G8JGELITEK (RASBURICASE) KIT [SANOFI-AVENTIS U.S. LLC]10
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74ELITEK (RASBURICASE) KIT [SANOFI-AVENTIS U.S. LLC]10
waterINACTIVE INGREDIENT059QF0KO0RELITEK (RASBURICASE) KIT [SANOFI-AVENTIS U.S. LLC]10