Sanofi-Aventis U.S. LLC
NDC labeler codes: 0024, 0075, 0088, 0955
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Enoxaparin sodiumLovenox · 24 products
- Insulin glargineLantus Solostar, Lantus, Semglee · 6 products
- DupilumabDupixent · 4 products
- Sevelamer carbonateRenvela · 4 products
- SarilumabKevzara · 4 products
- IsatuximabSarclisa, Sarclisa Escena · 3 products
- LeflunomideArava · 3 products
- DocetaxelBeizray, Docivyx · 3 products
- Insulin lisproHumalog, Humalog Kwikpen, Admelog · 3 products
- ClopidogrelPlavix · 2 products
- IrbesartanAvapro · 2 products
- Irbesartan and hydrochlorothiazideAvalide · 2 products
- AfliberceptZaltrap, Pavblu, Eylea Hd · 2 products
- Sodium ferric gluconate complexFerrlecit · 2 products
- Insulin aspartNovolog, Novolog Mix 70/30, Fiasp · 2 products
- AlirocumabPraluent · 2 products
- Insulin glulisineApidra, Apidra Solostar · 2 products
- DronedaroneMultaq · 1 product
- Fexinidazole1 product
- PlerixaforMozobil · 1 product
- RifapentinePriftin · 1 product
- Primaquine phosphate1 product
- Insulin glargine and lixisenatideSoliqua 100/33 · 1 product
- Zolpidem tartrateAmbien, Ambien CR, Edluar · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| July 9, 2026 | BLA761445 | Isatuximab SARCLISA ESCENA | Sanofi-Aventis U.S. LLC |
| February 14, 2025 | BLA761325 | Insulin aspart MERILOG, MERILOG SOLOSTAR | Sanofi-Aventis U.S. LLC |
| July 16, 2021 | NDA214429 | Fexinidazole FEXINIDAZOLE | Sanofi |
| March 2, 2020 | BLA761113 | Isatuximab SARCLISA | Sanofi Aventis Us |
| December 11, 2017 | BLA209196 | Insulin lispro ADMELOG, ADMELOG SOLOSTAR | Sanofi-Aventis Us |
| May 22, 2017 | BLA761037 | Sarilumab KEVZARA | Sanofi Synthelabo |
| March 28, 2017 | BLA761055 | Dupilumab DUPIXENT | Regeneron Pharmaceuticals |
| November 21, 2016 | BLA208673 | Insulin glargine and lixisenatide SOLIQUA 100/33 | Sanofi-Aventis Us |
| July 24, 2015 | BLA125559 | Alirocumab PRALUENT | Regeneron Pharmaceuticals |
| February 25, 2015 | BLA206538 | Insulin glargine TOUJEO MAX SOLOSTAR, TOUJEO SOLOSTAR | Sanofi Us Services |
| August 3, 2012 | BLA125418 | Aflibercept ZALTRAP | Sanofi Aventis Us |
| August 12, 2009 | NDA022318 | Sevelamer carbonate RENVELA | Genzyme |
| July 1, 2009 | NDA022425 | Dronedarone MULTAQ | Sanofi Aventis Us |
| December 15, 2008 | NDA022311 | Plerixafor MOZOBIL | Genzyme |
| October 19, 2007 | NDA022127 | Sevelamer carbonate RENVELA | Sanofi |
| April 16, 2004 | BLA021629 | Insulin glulisine APIDRA, APIDRA SOLOSTAR | Sanofi Aventis Us |
| April 20, 2000 | BLA021081 | Insulin glargine LANTUS, LANTUS SOLOSTAR | Sanofi Aventis Us |
| February 18, 1999 | NDA020955 | Sodium ferric gluconate complex FERRLECIT | Sanofi Aventis Us |
| September 10, 1998 | NDA020905 | Leflunomide ARAVA | Sanofi Aventis Us |
| June 22, 1998 | NDA021024 | Rifapentine PRIFTIN | Sanofi Aventis Us |
| November 17, 1997 | NDA020839 | Clopidogrel PLAVIX | Sanofi Aventis Us |
| September 30, 1997 | NDA020757 | Irbesartan AVAPRO | Sanofi Aventis Us |
| September 30, 1997 | NDA020758 | Irbesartan and hydrochlorothiazide AVALIDE | Sanofi Aventis Us |
| May 14, 1996 | NDA020449 | Docetaxel TAXOTERE | Sanofi Aventis Us |
| March 29, 1993 | NDA020164 | Enoxaparin sodium LOVENOX, LOVENOX (PRESERVATIVE FREE) | Sanofi Aventis Us |
| December 16, 1992 | NDA019908 | Zolpidem tartrate AMBIEN | Cosette |
| January 23, 1952 | NDA008316 | Primaquine phosphate PRIMAQUINE | Sanofi Aventis Us |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2023
-
April 11, 2023 · Class II · Ongoing · D-0575-2023 · Insulin lispro
Lack of Assurance of Sterility: Malformed crimped collar seal
Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A Sanofi Company. NDC 0024-5926-05
2018
-
July 5, 2018 · Class II · Ongoing · D-0925-2018 · Insulin lispro
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, NDC 0
-
April 27, 2018 · Class II · Terminated · D-0804-2018 · Docetaxel
Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01
2017
-
December 5, 2017 · Class III · Terminated · D-0153-2018 · Enoxaparin sodium
Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL
Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business of Sanofi-aventis, U.S. LLC Bridgewater, NJ 08807, NDC 0955-1012-10
2016
-
September 1, 2016 · Class III · Terminated · D-0704-2017 · Plerixafor
Labeling: Incorrect or Missing Package Insert
Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx Only, Manufactured by: Genzyme Corporation 500 Kendall Street, Cambridge, MA 02412 USA NDC: 0024-5862-01
-
August 4, 2016 · Class III · Terminated · D-1518-2016 · Plerixafor
Labeling: Incorrect or Missing Lot and/or Exp. Date
Mozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For Subcutaneous Injection only, Manufactured by: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 A Sanofi Company Country of Origin
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026