Home NDC 0024-5150 Elitek
Product NDC 0024-5150
11-digit product format 000245150
Labeler code 0024
Product ID 0024-5150_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 2002-07-12
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 0024-5150 I Inactivated by FDA excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0024-5150 0024-5150-10 I Inactivated by FDA excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…
Additional Listing Data#
Finished product Yes
Brand name base Elitek
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1790344 Internal RxNorm lookup 1790347 Internal RxNorm lookup 1790349 Internal RxNorm lookup 1790351 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2024-10-04 These 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 2024-10-04 These 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 2024-10-04 These 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 2024-07-30 These 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 2024-07-30 These 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 2024-07-30 These 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 2024-01-30 These 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 2024-01-30 These 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 2024-01-30 These 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 NDC Product Description Form Quantity Strength SPL version 0024-5150-10 Elitek 1 in 1 KIT KIT 1 23 0024-5150-10 Elitek 3 in 1 CARTON KIT 3 23 0024-5154-11 Elitek 1 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 1 mL 1.5 mg in 1mL 23
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0024-5150 ELITEK (RASBURICASE) KIT [SANOFI-AVENTIS U.S. LLC] 23 Current NDC, Legacy NDC, 3 package rows 20250515_0ae10bc4-6b65-402f-9db5-2d7753054922.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Elitek RASBURICASE Sanofi-Aventis U.S. LLC 0ae10bc4-6b65-402f-9db5-2d7753054922 2026-07-24 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA103946 ndc (product): 0024-5150
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103946 Elitek rasburicase 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0024-5150-10 00024515010 3 KIT in 1 CARTON (0024-5150-10) / 1 KIT in 1 KIT * 1 mL in 1 VIAL, SINGLE-USE (0024-5154-11) * 1 mL in 1 AMPULE (0024-5152-11) 3 kit 2002-07-12 0000-00-00 No No Current 0024-5154-11 00024515411 1 mL in 1 VIAL, SINGLE-USE 1 ml Historical