Praluent

Product NDC: 72733-5902
Requested package NDC: 72733-5902-2
11-digit product format: 727335902
Labeler code: 72733
Product ID: 72733-5902_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: 150 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	72733-5902	72733-5902-2	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 · 11 matching rows.

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72733-5902-2	2024-01-30	C162847	48780-1	1030e365-1e6b-111a-e063-dadaa90a10e2	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72733-5902-2	ML - Milliliter	72733-5902	95aebad5-723f-4b36-a931-d0bea753f7a8	1	2019-03-12

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72733-5902-2	72733590202	2 SYRINGE, GLASS in 1 CARTON (72733-5902-2) > 1 mL in 1 SYRINGE, GLASS (72733-5902-1)	2019-02-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Praluent	Sanofi US Corporation \| Regeneron Pharmaceuticals, Inc. \| Regn Ireland DAC \| Sanofi-Aventis Deutschland GmbH \| Genzyme Ireland Limited \| Sanofi Winthrop Industrie	2024-03-08	HUMAN PRESCRIPTION DRUG LABEL	13