Labeler · US market

Sanofi-Aventis U.S. LLC

Sanofi-Aventis U.S. LLC is a US drug labeler with US FDA registrations covering 33 drug concepts (30 currently active) across 105 packages. It is currently the only active US supplier of 13 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes0024 · 0068 · 0075 · 0088 · 0955

Active drugs30

Registrations79 active / 83

Packages105

Sole supplier of13 drugs

Portfolio33 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Enoxaparin Sodium injection	rx	21	21	SUPPLYING
Insulin Glargine injection, solution	rx	6	10	SUPPLYING
Dupilumab injection, solution	rx	5	10	SUPPLYING
Sarilumab injection, solution	rx	4	8	SUPPLYING
Alirocumab injection, solution	rx	2	4	SUPPLYING
Leflunomide tablet, film coated	rx	3	3	SUPPLYING
Dronedarone tablet, film coated	rx	1	3	SUPPLYING
Docetaxel injection, solution, concentrate	rx	3	3	SUPPLYING
Enoxaparin Sodium injection	rx	2	2	SUPPLYING
Insulin Lispro injection, solution	rx	1	2	SUPPLYING
Sevelamer Carbonate powder, for suspension	rx	2	2	SUPPLYING
Clopidogrel tablet, film coated	rx	2	2	SUPPLYING
Sevelamer Carbonate tablet, film coated	rx	2	2	SUPPLYING
Insulin Lispro injection, solution	rx	2	2	SUPPLYING
Insulin Glulisine injection, solution	rx	1	2	SUPPLYING
Irbesartan And Hydrochlorothiazide tablet, film coated	rx	2	2	SUPPLYING
Irbesartan tablet, film coated	rx	2	2	SUPPLYING
Rasburicase kit	rx	2	2	SUPPLYING
Ziv-Aflibercept solution, concentrate	rx	2	2	SUPPLYING
Insulin Aspart-Szjj injection, solution	rx	2	2	SUPPLYING
Insulin Glulisine injection, solution	rx	1	2	SUPPLYING
Sodium Ferric Gluconate Complex injection	rx	2	2	SUPPLYING
Fexinidazole tablet	rx	1	2	SUPPLYING
Insulin Glargine And Lixisenatide injection, solution	rx	1	2	SUPPLYING
Isatuximab injection, solution, concentrate	rx	2	2	SUPPLYING
Isatuximab-Irfc injection, solution	rx	1	1	SUPPLYING
Cabazitaxel kit	rx	1	1	SUPPLYING
Rifapentine tablet, film coated	rx	1	1	SUPPLYING
Primaquine Phosphate tablet, film coated	rx	1	1	SUPPLYING
Plerixafor injection, solution	rx	1	1	SUPPLYING
Zolpidem Tartrate tablet, film coated	rx	2	2	DISCONTINUED
Rifampin injection, powder, lyophilized, for solution	rx	1	1	DISCONTINUED
Zolpidem Tartrate tablet, coated	rx	1	1	DISCONTINUED

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

+3 more

At a glance

TypeLabeler
Labeler codes0024, 0068, 0075, 0088, 0955
Filing names1
Drugs (active)30
Drugs (all time)33
US registrations83
Packages105

Recent events

Shortages, recalls, and registration changes across all filing names.

Jun 8, 2026
RESOLVEDShortage resolved: Leflunomide Tablet (Sanofi-Aventis U.S. LLC)
Jun 8, 2026
SHORTAGEDrug shortage: Leflunomide Tablet (Sanofi-Aventis U.S. LLC)
Dec 10, 2025
RESOLVEDShortage resolved: Doxercalciferol Injection (Sanofi-Aventis U.S. LLC)
Dec 10, 2025
SHORTAGEDrug shortage: Doxercalciferol Injection (Sanofi-Aventis U.S. LLC)
Apr 11, 2023
RECALLRecall (Class II): Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgew…
Feb 17, 2021
SHORTAGEDrug shortage: Rifampin Injection (Sanofi-Aventis U.S. LLC)
Aug 10, 2020
RECALLRecall (Class II): Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC…
Mar 25, 2020
SHORTAGEDrug shortage: Rifapentine Tablet, Film Coated (Sanofi-Aventis U.S. LLC)

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile; figures cover the entity across all its filing names.