FDA.reportPublic FDA data

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

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
ndc (product): 61755-020
PraluentALIROCUMABSanofi-Aventis U.S. LLC446f6b5c-0dd4-44ff-9bc2-c2b41f2806b42026-07-07Warnings, Adverse reactionsExact identifier
application number: BLA125559

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALIROCUMAB75 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1659156Internal RxNorm lookup
1659161Internal 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
7bcfbac2-e8ac-4569-8edc-bcde3b1fd172Available 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
61755-020-012024-01-30C16284748780-11030e365-0b1f-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
61755-020-012024-01-30C16284748780-11030e365-0b1f-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
61755-020-012024-01-30C16284748780-11030e365-0b1f-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
61755-020-022024-01-30C16284748780-11030e365-0b1f-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
61755-020-022024-01-30C16284748780-11030e365-0b1f-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
61755-020-022024-01-30C16284748780-11030e365-0b1f-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
61755-020-042024-01-30C16284748780-11030e365-0b1f-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
61755-020-042024-01-30C16284748780-11030e365-0b1f-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
61755-020-042024-01-30C16284748780-11030e365-0b1f-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
61755-020-01Praluent1 in 1 CARTONINJECTION, SOLUTION19
61755-020-01Praluent1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION19
61755-020-02Praluent1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION19
61755-020-02Praluent2 in 1 CARTONINJECTION, SOLUTION29
61755-020-04Praluent1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION19
61755-020-04Praluent1 in 1 CARTONINJECTION, SOLUTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61755-020-01ML - Milliliter61755-02055bd1300-6560-485b-95f1-bc981be49ad912022-09-12
61755-020-02ML - Milliliter61755-0206877d2c3-fe63-467e-b784-922540be618212021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61755-020PRALUENT (ALIROCUMAB) INJECTION, SOLUTION [REGENERON PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 6 package rows20240405_7bcfbac2-e8ac-4569-8edc-bcde3b1fd172.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-InjectorPSN7bcfbac2-e8ac-4569-8edc-bcde3b1fd1729
1659182alirocumab 75 MG in 1 ML Auto-InjectorPSN7bcfbac2-e8ac-4569-8edc-bcde3b1fd1729
1659161Praluent 150 MG in 1 ML Auto-InjectorPSN7bcfbac2-e8ac-4569-8edc-bcde3b1fd1729
1659183Praluent 75 MG in 1 ML Auto-InjectorPSN7bcfbac2-e8ac-4569-8edc-bcde3b1fd1729
16591611 ML alirocumab 150 MG/ML Auto-Injector [Praluent]SBD7bcfbac2-e8ac-4569-8edc-bcde3b1fd1729
16591831 ML alirocumab 75 MG/ML Auto-Injector [Praluent]SBD7bcfbac2-e8ac-4569-8edc-bcde3b1fd1729
16591561 ML alirocumab 150 MG/ML Auto-InjectorSCD7bcfbac2-e8ac-4569-8edc-bcde3b1fd1729
16591821 ML alirocumab 75 MG/ML Auto-InjectorSCD7bcfbac2-e8ac-4569-8edc-bcde3b1fd1729
16591611 ML Praluent 150 MG/ML Auto-InjectorSY7bcfbac2-e8ac-4569-8edc-bcde3b1fd1729
16591831 ML Praluent 75 MG/ML Auto-InjectorSY7bcfbac2-e8ac-4569-8edc-bcde3b1fd1729
1659156alirocumab 150 MG per 1 ML Auto-InjectorSY7bcfbac2-e8ac-4569-8edc-bcde3b1fd1729
1659182alirocumab 75 MG per 1 ML Auto-InjectorSY7bcfbac2-e8ac-4569-8edc-bcde3b1fd1729
1659161Praluent 150 MG per 1 ML Auto-InjectorSY7bcfbac2-e8ac-4569-8edc-bcde3b1fd1729
1659183Praluent 75 MG per 1 ML Auto-InjectorSY7bcfbac2-e8ac-4569-8edc-bcde3b1fd1729

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61755-020-01617550020011 SYRINGE, GLASS in 1 CARTON (61755-020-01) / 1 mL in 1 SYRINGE, GLASS2020-12-010000-00-00NoNoCurrent
61755-020-02617550020022 SYRINGE, GLASS in 1 CARTON (61755-020-02) / 1 mL in 1 SYRINGE, GLASS2020-12-010000-00-00NoNoCurrent
61755-020-04617550020041 SYRINGE, GLASS in 1 CARTON (61755-020-04) / 1 mL in 1 SYRINGE, GLASS2020-12-010000-00-00YesNoCurrent