FDA.reportPublic FDA data

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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0024-59020024-5902-02DDiscontinued by firm2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PraluentALIROCUMABRegeneron Pharmaceuticals, Inc.7bcfbac2-e8ac-4569-8edc-bcde3b1fd1722026-07-16Warnings, Adverse reactionsExact identifier
application number: BLA125559
PraluentALIROCUMABSanofi-Aventis U.S. LLC446f6b5c-0dd4-44ff-9bc2-c2b41f2806b42026-07-07Warnings, Adverse reactionsExact identifier
application number: BLA125559
ndc (product): 0024-5902

Additional Listing Data#

Finished product
Yes
Brand name base
Praluent
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALIROCUMAB150 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PP0SHH6V16Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1659156Internal RxNorm lookup
1659161Internal RxNorm lookup
1659165Internal RxNorm lookup
1659167Internal RxNorm lookup
1659177Internal RxNorm lookup
1659179Internal RxNorm lookup
1659182Internal RxNorm lookup
1659183Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ab434c1f-2b4e-461c-92e8-506132dea02aProduct name120190716
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0024-5902-002024-01-30C16284748780-11030e365-3cfe-111a-e063-dadaa90a10e2These 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
0024-5902-002024-01-30C16284748780-11030e365-3cfe-111a-e063-dadaa90a10e2These 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
0024-5902-002024-01-30C16284748780-11030e365-3cfe-111a-e063-dadaa90a10e2These 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
0024-5902-012024-01-30C16284748780-11030e365-3cfe-111a-e063-dadaa90a10e2These 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
0024-5902-012024-01-30C16284748780-11030e365-3cfe-111a-e063-dadaa90a10e2These 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
0024-5902-012024-01-30C16284748780-11030e365-3cfe-111a-e063-dadaa90a10e2These 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
0024-5902-022024-01-30C16284748780-11030e365-3cfe-111a-e063-dadaa90a10e2These 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
0024-5902-022024-01-30C16284748780-11030e365-3cfe-111a-e063-dadaa90a10e2These 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
0024-5902-022024-01-30C16284748780-11030e365-3cfe-111a-e063-dadaa90a10e2These 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 NDCProductDescriptionFormQuantityStrengthSPL version
0024-5902-00Praluent1 in 1 CARTONINJECTION, SOLUTION133
0024-5902-00Praluent1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION133
0024-5902-01Praluent1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION133
0024-5902-01Praluent1 in 1 CARTONINJECTION, SOLUTION133
0024-5902-02Praluent1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION133
0024-5902-02Praluent2 in 1 CARTONINJECTION, SOLUTION233

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-5902-00ML - Milliliter0024-590299a029c8-f08e-499e-9291-c7e58661f80212019-09-05
0024-5902-01ML - Milliliter0024-5902a496b57c-a161-4f11-826e-62bd3a68eda512015-09-10
0024-5902-02ML - Milliliter0024-5902790059a6-c56b-4030-a6c2-caa398fd436e12015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
alirocumabACTIVE INGREDIENTPP0SHH6V16PRALUENT (ALIROCUMAB) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]1
alirocumabACTIVE MOIETYPP0SHH6V16PRALUENT (ALIROCUMAB) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]1
histidineINACTIVE INGREDIENT4QD397987EPRALUENT (ALIROCUMAB) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]1
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHPRALUENT (ALIROCUMAB) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]1
sucroseINACTIVE INGREDIENTC151H8M554PRALUENT (ALIROCUMAB) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]1
waterINACTIVE INGREDIENT059QF0KO0RPRALUENT (ALIROCUMAB) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-5902PRALUENT (ALIROCUMAB) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]31Current NDC, Legacy NDC, 6 package rows20240912_446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125559Praluentalirocumab351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659156alirocumab 150 MG in 1 ML Auto-InjectorPSN446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
1659165alirocumab 150 MG in 1 ML Prefilled SyringePSN446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
1659182alirocumab 75 MG in 1 ML Auto-InjectorPSN446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
1659177alirocumab 75 MG in 1 ML Prefilled SyringePSN446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
1659161Praluent 150 MG in 1 ML Auto-InjectorPSN446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
1659167Praluent 150 MG in 1 ML Prefilled SyringePSN446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
1659183Praluent 75 MG in 1 ML Auto-InjectorPSN446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
1659179Praluent 75 MG in 1 ML Prefilled SyringePSN446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
16591611 ML alirocumab 150 MG/ML Auto-Injector [Praluent]SBD446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
16591671 ML alirocumab 150 MG/ML Prefilled Syringe [Praluent]SBD446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
16591831 ML alirocumab 75 MG/ML Auto-Injector [Praluent]SBD446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
16591791 ML alirocumab 75 MG/ML Prefilled Syringe [Praluent]SBD446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
16591561 ML alirocumab 150 MG/ML Auto-InjectorSCD446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
16591651 ML alirocumab 150 MG/ML Prefilled SyringeSCD446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
16591821 ML alirocumab 75 MG/ML Auto-InjectorSCD446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
16591771 ML alirocumab 75 MG/ML Prefilled SyringeSCD446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
16591611 ML Praluent 150 MG/ML Auto-InjectorSY446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
16591671 ML Praluent 150 MG/ML Prefilled SyringeSY446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
16591831 ML Praluent 75 MG/ML Auto-InjectorSY446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
16591791 ML Praluent 75 MG/ML Prefilled SyringeSY446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
1659156alirocumab 150 MG per 1 ML Auto-InjectorSY446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
1659182alirocumab 75 MG per 1 ML Auto-InjectorSY446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
1659161Praluent 150 MG per 1 ML Auto-InjectorSY446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
1659183Praluent 75 MG per 1 ML Auto-InjectorSY446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433
1659179Praluent 75 MG per 1 ML Prefilled SyringeSY446f6b5c-0dd4-44ff-9bc2-c2b41f2806b433

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0024-5902-00000245902001 SYRINGE, GLASS in 1 CARTON (0024-5902-00) / 1 mL in 1 SYRINGE, GLASS2015-07-240000-00-00YesNoCurrent
0024-5902-01000245902011 SYRINGE, GLASS in 1 CARTON (0024-5902-01) / 1 mL in 1 SYRINGE, GLASS2015-07-240000-00-00NoNoCurrent
0024-5902-02000245902022 SYRINGE, GLASS in 1 CARTON (0024-5902-02) > 1 mL in 1 SYRINGE, GLASS2015-07-240000-00-00NoNoCurrent