FDA.reportPublic FDA data

Praluent

Product NDC
0024-5901
11-digit product format
000245901
Labeler code
0024
Product ID
0024-5901_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
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALIROCUMAB75 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPP0SHH6V16
Rxcui1659156, 1659161, 1659165, 1659167, 1659177, 1659179, 1659182, 1659183

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
0024-5901-002024-01-30C16284748780-11030e365-3cfe-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
0024-5901-002024-01-30C16284748780-11030e365-3cfe-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
0024-5901-012024-01-30C16284748780-11030e365-3cfe-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
0024-5901-012024-01-30C16284748780-11030e365-3cfe-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
0024-5901-022024-01-30C16284748780-11030e365-3cfe-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
0024-5901-022024-01-30C16284748780-11030e365-3cfe-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
0024-5901-00Praluent1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION133
0024-5901-00Praluent1 in 1 CARTONINJECTION, SOLUTION133
0024-5901-01Praluent1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION133
0024-5901-01Praluent1 in 1 CARTONINJECTION, SOLUTION133
0024-5901-02Praluent2 in 1 CARTONINJECTION, SOLUTION233
0024-5901-02Praluent1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION133

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-5901-01ML - Milliliter0024-5901413378a9-5222-4279-a58a-44100bbb168b12015-09-10
0024-5901-02ML - Milliliter0024-5901e225787e-1da7-4890-a4d4-c696e6a6924b12015-08-04

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
0024-5901PRALUENT (ALIROCUMAB) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]31Current NDC, Legacy NDC, 6 package rows20240912_446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4.zip

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
0024-5901-00000245901001 SYRINGE, GLASS in 1 CARTON (0024-5901-00) / 1 mL in 1 SYRINGE, GLASS2015-07-240000-00-00YesNoCurrent
0024-5901-01000245901011 SYRINGE, GLASS in 1 CARTON (0024-5901-01) / 1 mL in 1 SYRINGE, GLASS2015-07-240000-00-00NoNoCurrent
0024-5901-02000245901022 SYRINGE, GLASS in 1 CARTON (0024-5901-02) > 1 mL in 1 SYRINGE, GLASS2015-07-240000-00-00NoNoCurrent