FDA.reportPublic FDA data

Praluent

Product NDC
72733-5901
Requested package NDC
72733-5901-2
11-digit product format
727335901
Labeler code
72733
Product ID
72733-5901_9f6bfdfc-2991-4bd3-85c8-0f0c446f6d1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alirocumab
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Sanofi US Corporation
Application
BLA125559
Marketing category
BLA
Marketing start
2019-02-15
Marketing end
0000-00-00
Substance
ALIROCUMAB
Active strength
75 mg/mL
Pharmacologic classes
PCSK9 Inhibitor [EPC],PCSK9 Inhibitors [MoA],Antibodies, Monoclonal [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage72733-590172733-5901-2DDiscontinued 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72733-5901-22024-01-30C16284748780-11030e365-1e6b-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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72733-5901-1ML - Milliliter72733-5901a1a75f0c-7a38-41bc-970e-765cef07391512021-06-02
72733-5901-2ML - Milliliter72733-5901c8903bf5-b2d2-44cf-b84d-e4661980a21b12019-03-12

Purple Book Biologic Products#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72733-5901-2727335901022 SYRINGE, GLASS in 1 CARTON (72733-5901-2) > 1 mL in 1 SYRINGE, GLASS (72733-5901-1) 2019-02-150000-00-00NoNoCurrent