Home NDC 0024-5902 Praluent
Product NDC 0024-5902
11-digit product format 000245902
Labeler code 0024
Product ID 0024-5902_4b8a5125-bbdb-45dd-bcd3-2f5e030e4dc6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name alirocumab
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Sanofi-Aventis U.S. LLC
Application BLA125559
Marketing category BLA
Marketing start 2015-07-24
Substance ALIROCUMAB
Active strength 150 mg/mL
Pharmacologic classes Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]
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 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
Additional Listing Data#
Finished product Yes
Brand name base Praluent
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALIROCUMAB 150 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PP0SHH6V16 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1659156 Internal RxNorm lookup 1659161 Internal RxNorm lookup 1659165 Internal RxNorm lookup 1659167 Internal RxNorm lookup 1659177 Internal RxNorm lookup 1659179 Internal RxNorm lookup 1659182 Internal RxNorm lookup 1659183 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# NDC, Related label table NDC Related label 0024-5902-00 These highlights do not include all the information needed to use PRALUENT safely and effectively. See full prescribing information for PRALUENT. PRALUENT ® (alirocumab) injection, for subcutaneous use Initial U.S. Approval: 2015 0024-5902-00 These highlights do not include all the information needed to use PRALUENT safely and effectively. See full prescribing information for PRALUENT. PRALUENT ® (alirocumab) injection, for subcutaneous use Initial U.S. Approval: 2015 0024-5902-00 These highlights do not include all the information needed to use PRALUENT safely and effectively. See full prescribing information for PRALUENT. PRALUENT ® (alirocumab) injection, for subcutaneous use Initial U.S. Approval: 2015 0024-5902-01 These highlights do not include all the information needed to use PRALUENT safely and effectively. See full prescribing information for PRALUENT. PRALUENT ® (alirocumab) injection, for subcutaneous use Initial U.S. Approval: 2015 0024-5902-01 These highlights do not include all the information needed to use PRALUENT safely and effectively. See full prescribing information for PRALUENT. PRALUENT ® (alirocumab) injection, for subcutaneous use Initial U.S. Approval: 2015 0024-5902-01 These highlights do not include all the information needed to use PRALUENT safely and effectively. See full prescribing information for PRALUENT. PRALUENT ® (alirocumab) injection, for subcutaneous use Initial U.S. Approval: 2015 0024-5902-02 These highlights do not include all the information needed to use PRALUENT safely and effectively. See full prescribing information for PRALUENT. PRALUENT ® (alirocumab) injection, for subcutaneous use Initial U.S. Approval: 2015 0024-5902-02 These highlights do not include all the information needed to use PRALUENT safely and effectively. See full prescribing information for PRALUENT. PRALUENT ® (alirocumab) injection, for subcutaneous use Initial U.S. Approval: 2015 0024-5902-02 These highlights do not include all the information needed to use PRALUENT safely and effectively. See full prescribing information for PRALUENT. PRALUENT ® (alirocumab) injection, for subcutaneous use Initial U.S. Approval: 2015
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0024-5902-00 Praluent 1 in 1 CARTON INJECTION, SOLUTION 1 33 0024-5902-00 Praluent 1 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 1 33 0024-5902-01 Praluent 1 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 1 33 0024-5902-01 Praluent 1 in 1 CARTON INJECTION, SOLUTION 1 33 0024-5902-02 Praluent 1 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 1 33 0024-5902-02 Praluent 2 in 1 CARTON INJECTION, SOLUTION 2 33
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0024-5902 PRALUENT (ALIROCUMAB) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC] 31 Current NDC, Legacy NDC, 6 package rows 20240912_446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4.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 · 2 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125559 Praluent alirocumab 351(a) Rx 2026-08-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0024-5902-00 00024590200 1 SYRINGE, GLASS in 1 CARTON (0024-5902-00) / 1 mL in 1 SYRINGE, GLASS 2015-07-24 0000-00-00 Yes No Current 0024-5902-01 00024590201 1 SYRINGE, GLASS in 1 CARTON (0024-5902-01) / 1 mL in 1 SYRINGE, GLASS 2015-07-24 0000-00-00 No No Current 0024-5902-02 00024590202 2 SYRINGE, GLASS in 1 CARTON (0024-5902-02) > 1 mL in 1 SYRINGE, GLASS 2015-07-24 0000-00-00 No No Current