Praluent

Product NDC: 0024-5903
11-digit product format: 000245903
Labeler code: 0024
Product ID: 0024-5903_d6e3eeb8-c775-4382-85c3-3f3e8999c280
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
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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0024-5903		D	Discontinued by firm	2026-08-17
excluded package	package	0024-5903	0024-5903-00	D	Discontinued by firm	2026-08-17
excluded package	package	0024-5903	0024-5903-01	D	Discontinued by firm	2026-08-17
excluded package	package	0024-5903	0024-5903-02	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 37 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0024-5903-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0024-5903-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0024-5903-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0024-5903-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0024-5903-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0024-5903-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0024-5903-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0024-5903-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0024-5903-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0024-5903-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0024-5903-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0024-5903-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0024-5903-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0024-5903-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0024-5903-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0024-5903-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0024-5903-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0024-5903-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0024-5903-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0024-5903-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0024-5903-00	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0024-5903-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0024-5903-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0024-5903-00	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0024-5903-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0024-5903-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0024-5903-00	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0024-5903-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0024-5903-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0024-5903-00	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0024-5903-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0024-5903-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0024-5903-00	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0024-5903-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0024-5903-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0024-5903-00	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ab434c1f-2b4e-461c-92e8-506132dea02a	Product name	1	20190716
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
0024-5903-00	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
0024-5903-00	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
0024-5903-00	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
0024-5903-01	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
0024-5903-01	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
0024-5903-01	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
0024-5903-02	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
0024-5903-02	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
0024-5903-02	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0024-5903-00	Praluent	1 in 1 BLISTER PACK	INJECTION, SOLUTION	1	33
0024-5903-00	Praluent	1 in 1 CARTON	INJECTION, SOLUTION	1	33
0024-5903-01	Praluent	1 in 1 BLISTER PACK	INJECTION, SOLUTION	1	33
0024-5903-01	Praluent	1 in 1 CARTON	INJECTION, SOLUTION	1	33
0024-5903-02	Praluent	2 in 1 CARTON	INJECTION, SOLUTION	2	33
0024-5903-02	Praluent	1 in 1 BLISTER PACK	INJECTION, SOLUTION	1	33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0024-5903-01	ML - Milliliter	0024-5903	2bacd04a-7172-4729-90dd-5c2c55edda0e	1	2015-09-10
0024-5903-02	ML - Milliliter	0024-5903	ed9e2db0-77be-4b9e-89d0-fb2583da381b	1	2015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
alirocumab	ACTIVE INGREDIENT	PP0SHH6V16	PRALUENT (ALIROCUMAB) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]	1
alirocumab	ACTIVE MOIETY	PP0SHH6V16	PRALUENT (ALIROCUMAB) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]	1
histidine	INACTIVE INGREDIENT	4QD397987E	PRALUENT (ALIROCUMAB) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]	1
polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	PRALUENT (ALIROCUMAB) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]	1
sucrose	INACTIVE INGREDIENT	C151H8M554	PRALUENT (ALIROCUMAB) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]	1
water	INACTIVE INGREDIENT	059QF0KO0R	PRALUENT (ALIROCUMAB) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0024-5903	PRALUENT (ALIROCUMAB) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]	31	Legacy NDC, 6 package rows	20240912_446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Praluent	ALIROCUMAB	Regeneron Pharmaceuticals, Inc.	7bcfbac2-e8ac-4569-8edc-bcde3b1fd172	2026-07-16	Warnings, Adverse reactions	Exact identifier application number: BLA125559
Praluent	ALIROCUMAB	Sanofi-Aventis U.S. LLC	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	2026-07-07	Warnings, Adverse reactions	Exact identifier application number: BLA125559 ndc (product): 0024-5903

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PP0SHH6V16	ALIROCUMAB	1245916-14-6	ALIROCUMAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1659156	alirocumab 150 MG in 1 ML Auto-Injector	PSN	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659165	alirocumab 150 MG in 1 ML Prefilled Syringe	PSN	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659182	alirocumab 75 MG in 1 ML Auto-Injector	PSN	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659177	alirocumab 75 MG in 1 ML Prefilled Syringe	PSN	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659161	Praluent 150 MG in 1 ML Auto-Injector	PSN	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659167	Praluent 150 MG in 1 ML Prefilled Syringe	PSN	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659183	Praluent 75 MG in 1 ML Auto-Injector	PSN	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659179	Praluent 75 MG in 1 ML Prefilled Syringe	PSN	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659161	1 ML alirocumab 150 MG/ML Auto-Injector [Praluent]	SBD	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659167	1 ML alirocumab 150 MG/ML Prefilled Syringe [Praluent]	SBD	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659183	1 ML alirocumab 75 MG/ML Auto-Injector [Praluent]	SBD	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659179	1 ML alirocumab 75 MG/ML Prefilled Syringe [Praluent]	SBD	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659156	1 ML alirocumab 150 MG/ML Auto-Injector	SCD	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659165	1 ML alirocumab 150 MG/ML Prefilled Syringe	SCD	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659182	1 ML alirocumab 75 MG/ML Auto-Injector	SCD	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659177	1 ML alirocumab 75 MG/ML Prefilled Syringe	SCD	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659161	1 ML Praluent 150 MG/ML Auto-Injector	SY	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659167	1 ML Praluent 150 MG/ML Prefilled Syringe	SY	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659183	1 ML Praluent 75 MG/ML Auto-Injector	SY	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659179	1 ML Praluent 75 MG/ML Prefilled Syringe	SY	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659156	alirocumab 150 MG per 1 ML Auto-Injector	SY	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659182	alirocumab 75 MG per 1 ML Auto-Injector	SY	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659161	Praluent 150 MG per 1 ML Auto-Injector	SY	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659183	Praluent 75 MG per 1 ML Auto-Injector	SY	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33
1659179	Praluent 75 MG per 1 ML Prefilled Syringe	SY	446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4	33

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
0024-5903-00	00024590300	1 in 1 BLISTER PACK	Historical
0024-5903-01	00024590301	1 in 1 BLISTER PACK	Historical
0024-5903-02	00024590302	2 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Praluent	Sanofi-Aventis U.S. LLC \| Regeneron Pharmaceuticals, Inc. \| Sanofi Winthrop Industrie \| Sanofi Vaccines US Inc. \| Regeneron Ireland Designated Activity Company \| Sanofi-Aventis Deutschland GmbH \| Genzyme Ireland Limited	2026-07-07	HUMAN PRESCRIPTION DRUG LABEL	35