PriceTracker GLP-1

What FDA’s records state

FDA listing summary for Amneal Pharmaceuticals LLC
FieldWhat FDA’s record statesSource
Firm, as FDA lists itAmneal Pharmaceuticals LLCopenFDA NDC
Also listed asNo other spellingopenFDA NDC
FDA labeler code70121openFDA NDC
MoleculesExenatideopenFDA NDC
Kinds of listingApproved product: 2openFDA NDC
Products and packages2 products, 2 package NDCsopenFDA NDC
Earliest listing dateNov 22, 2024openFDA NDC
Latest listing dateNov 22, 2024openFDA NDC
Approved applications citedANDA206697 (EXENATIDE SYNTHETIC), held by AMNEAL, first approved Nov 19, 2024Drugs@FDA

Every GLP-1 product Amneal Pharmaceuticals 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 Amneal Pharmaceuticals LLC
ProductProduct NDCForm and strengthFDA categoryListedPackages
Exenatide70121-1685Injection · Subcutaneous250 ug/mLApproved productANDA · ANDA206697Since Nov 22, 2024Marketing ends Jun 30, 2027
1 package
  • 70121-1685-1 1 CARTRIDGE in 1 CARTON / 1.2 mL in 1 CARTRIDGE, since Nov 22, 2024
Exenatide70121-1686Injection · Subcutaneous250 ug/mLApproved productANDA · ANDA206697Since Nov 22, 2024Marketing ends May 31, 2027
1 package
  • 70121-1686-1 1 CARTRIDGE in 1 CARTON / 2.4 mL in 1 CARTRIDGE, since Nov 22, 2024

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. Exenatide is the ingredient in Byetta.

“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

Other firms listing exenatide

FDA registers on this site

Sources

  • FDA NDC directory via openFDA ↗, updated by FDA .
  • 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.