Sanofi-Aventis U.S. LLC: GLP-1 NDC Listings (Oct 2026)

What FDA’s records state

FDA listing summary for Sanofi-Aventis U.S. LLC
Field	What FDA’s record states	Source
Firm, as FDA lists it	Sanofi-Aventis U.S. LLC	openFDA NDC
Also listed as	No other spelling	openFDA NDC
FDA labeler code	0024	openFDA NDC
Molecules	Lixisenatide	openFDA NDC
Kinds of listing	Approved product: 1	openFDA NDC
Products and packages	1 product, 2 package NDCs	openFDA NDC
Earliest listing date	Nov 21, 2016	openFDA NDC
Latest listing date	Nov 21, 2016	openFDA NDC
Approved applications cited	BLA208673 (SOLIQUA 100/33), held by SANOFI-AVENTIS US, first approved Nov 21, 2016	Drugs@FDA

Every GLP-1 product Sanofi-Aventis U.S. LLC lists

One row per product NDC, in FDA’s words. Strength is printed as FDA lists it, spacing tidied.

GLP-1 products listed with FDA by Sanofi-Aventis U.S. LLC
Product	Product NDC	Form and strength	FDA category	Listed	Packages
Soliqua 100/33Lixisenatide	0024-5761	Injection, Solution · SubcutaneousInsulin Glargine 100 U/mL; Lixisenatide 33 ug/mL	Approved productBLA · BLA208673	Since Nov 21, 2016Certified through Dec 31, 2027	2 packages 0024-5761-01 1 SYRINGE in 1 CARTON / 3 mL in 1 SYRINGE, since Nov 21, 2016 0024-5761-05 5 SYRINGE in 1 CARTON / 3 mL in 1 SYRINGE, since Nov 21, 2016

The rest of its federal record

Checked against every GLP-1 record we publish from FDA. A recall or shortage counts when FDA printed one of this firm’s NDCs in it; a letter or 503B entry counts when the firm name matches exactly. Similar names are listed apart and not counted.

503B outsourcing facility register

Not on the register under this name.

GLP-1 warning letters

None of the GLP-1 warning letters we hold is addressed to this name.

GLP-1 recalls

No GLP-1 recall in FDA’s enforcement reports matches this firm.

FDA enforcement reports, updated by FDA Sep 23, 2026. Every GLP-1 recall

FDA drug shortage list

None of this firm’s NDCs is on FDA’s GLP-1 shortage entries.

FDA drug shortages ↗, updated by FDA Oct 2, 2026.

What these listings mean, and what they do not

Approved product. A finished product sold under an approved application (NDA, BLA or ANDA). The approval belongs to the application, which Drugs@FDA lists with its holder; the NDC is only the product's identifier.

A listing is not an approval, and not a quality check. It tells FDA a firm makes, labels or compounds a drug. Whether a product was approved is a question about its application, shown above where there is one. Whether a plant passed inspection is a different record again.

The molecules. Lixisenatide is the ingredient in Soliqua.

“Inclusion in the NDC Directory does not indicate that FDA has verified the information provided or that the products are FDA-approved.”FDA, National Drug Code Directory page, confirmed on the page Oct 4, 2026. fda.gov ↗

“Assignment of an NDC number does not in any way denote FDA approval of the product.”FDA, National Drug Code Directory page, confirmed on the page Oct 4, 2026. fda.gov ↗

“A labeler may be a manufacturer, including a repackager or relabeler, or the entity named on the product label.”FDA, National Drug Code Directory page, confirmed on the page Oct 4, 2026. fda.gov ↗

“The content of each NDC Directory entry is the responsibility of the labeler submitting the SPL file.”FDA, National Drug Code Directory page, confirmed on the page Oct 4, 2026. fda.gov ↗

Related records

FDA registers on this site

Sources

FDA NDC directory via openFDA ↗, updated by FDA Oct 2, 2026.
Application holders: Drugs@FDA, updated by FDA Oct 2, 2026.
FDA’s National Drug Code Directory page ↗ for the quoted definitions.
Read by us Oct 4, 2026. Not medical advice; this page describes filings, not products’ safety.