FDA.reportPublic FDA data

Elitek

Product NDC
0024-5151
11-digit product format
000245151
Labeler code
0024
Product ID
0024-5151_3a3ae025-e245-421a-bb4d-d200c29281b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rasburicase
Dosage form
KIT
Labeler
Sanofi-Aventis U.S. LLC
Application
BLA103946
Marketing category
BLA
Marketing start
2006-06-01
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Elitek
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1790344, 1790347, 1790349, 1790351

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
26fe94f2-ddca-4952-8728-4e5f5cd5364fProduct name120160803
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0024-5151-752024-10-04C16284748780-11030e365-65eb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Elitek safely and effectively. See full prescribing information for Elitek ® . ELITEK (rasburicase) for injection, for intravenous use Initial U.S. Approval: 2002
0024-5151-752024-07-30C16284748780-11030e365-65eb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Elitek safely and effectively. See full prescribing information for Elitek ® . ELITEK (rasburicase) for injection, for intravenous use Initial U.S. Approval: 2002
0024-5151-752024-01-30C16284748780-11030e365-65eb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Elitek safely and effectively. See full prescribing information for Elitek ® . ELITEK (rasburicase) for injection, for intravenous use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0024-5151-75Elitek1 in 1 CARTONKIT123
0024-5155-74Elitek5 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,5 mL7.5 mg in 5mL23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-5151-75EA - Each0024-515185a5b1c2-feae-49cd-8d75-ebac6393ffb812012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-5151ELITEK (RASBURICASE) KIT [SANOFI-AVENTIS U.S. LLC]23Current NDC, Legacy NDC, 2 package rows20250515_0ae10bc4-6b65-402f-9db5-2d7753054922.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790347ELITEK 1.5 MG InjectionPSN0ae10bc4-6b65-402f-9db5-2d775305492223
1790351ELITEK 7.5 MG InjectionPSN0ae10bc4-6b65-402f-9db5-2d775305492223
1790344rasburicase 1.5 MG InjectionPSN0ae10bc4-6b65-402f-9db5-2d775305492223
1790349rasburicase 7.5 MG InjectionPSN0ae10bc4-6b65-402f-9db5-2d775305492223
1790347rasburicase 1.5 MG Injection [Elitek]SBD0ae10bc4-6b65-402f-9db5-2d775305492223
1790351rasburicase 7.5 MG Injection [Elitek]SBD0ae10bc4-6b65-402f-9db5-2d775305492223
1790344rasburicase 1.5 MG InjectionSCD0ae10bc4-6b65-402f-9db5-2d775305492223
1790349rasburicase 7.5 MG InjectionSCD0ae10bc4-6b65-402f-9db5-2d775305492223
1790347Elitek 1.5 MG InjectionSY0ae10bc4-6b65-402f-9db5-2d775305492223
1790351Elitek 7.5 MG InjectionSY0ae10bc4-6b65-402f-9db5-2d775305492223

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0024-5151-75000245151751 KIT in 1 CARTON (0024-5151-75) * 5 mL in 1 VIAL, SINGLE-USE (0024-5155-74) * 5 mL in 1 AMPULE (0024-5153-74) 1 kit2006-06-010000-00-00NoNoCurrent
0024-5155-74000245155745 mL in 1 VIAL, SINGLE-USE5 mlHistorical