Home NDC 61755-020 Praluent
Product NDC 61755-020
11-digit product format 617550020
Labeler code 61755
Product ID 61755-020_ad540294-d141-4655-a97b-abc9ae2795a3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name alirocumab
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Regeneron Pharmaceuticals, Inc.
Application BLA125559
Marketing category BLA
Marketing start 2020-12-01
Substance ALIROCUMAB
Active strength 75 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 Additional Listing Data#
Finished product Yes
Brand name base Praluent
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALIROCUMAB 75 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1659156 Internal RxNorm lookup 1659161 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 61755-020-01 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 61755-020-01 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 61755-020-01 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 61755-020-02 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 61755-020-02 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 61755-020-02 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 61755-020-04 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 61755-020-04 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 61755-020-04 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 61755-020-01 Praluent 1 in 1 CARTON INJECTION, SOLUTION 1 9 61755-020-01 Praluent 1 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 1 9 61755-020-02 Praluent 1 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 1 9 61755-020-02 Praluent 2 in 1 CARTON INJECTION, SOLUTION 2 9 61755-020-04 Praluent 1 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 1 9 61755-020-04 Praluent 1 in 1 CARTON INJECTION, SOLUTION 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61755-020 PRALUENT (ALIROCUMAB) INJECTION, SOLUTION [REGENERON PHARMACEUTICALS, INC.] 7 Current NDC, Legacy NDC, 6 package rows 20240405_7bcfbac2-e8ac-4569-8edc-bcde3b1fd172.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 61755-020-01 61755002001 1 SYRINGE, GLASS in 1 CARTON (61755-020-01) / 1 mL in 1 SYRINGE, GLASS 2020-12-01 0000-00-00 No No Current 61755-020-02 61755002002 2 SYRINGE, GLASS in 1 CARTON (61755-020-02) / 1 mL in 1 SYRINGE, GLASS 2020-12-01 0000-00-00 No No Current 61755-020-04 61755002004 1 SYRINGE, GLASS in 1 CARTON (61755-020-04) / 1 mL in 1 SYRINGE, GLASS 2020-12-01 0000-00-00 Yes No Current