Every GLP-1 product Eli Lilly Italia SPA lists
One row per product NDC, in FDA’s words. Strength is printed as FDA lists it, spacing tidied.
| Product | Product NDC | Form and strength | FDA category | Listed | Packages |
|---|---|---|---|---|---|
| tirzepatide | 54568-043 | Injection, Solution5 mg/0.5 mL | Unfinished, for further processingDRUG FOR FURTHER PROCESSING | Since Aug 12, 2022Certified through Dec 31, 2026 | 1 package
|
| tirzepatide | 54568-170 | Injection, Solution2.5 mg/0.5 mL | Unfinished, for further processingDRUG FOR FURTHER PROCESSING | Since Aug 12, 2022Certified through Dec 31, 2026 | 1 package
|
| tirzepatide | 54568-325 | Injection, Solution15 mg/0.5 mL | Unfinished, for further processingDRUG FOR FURTHER PROCESSING | Since Jul 13, 2023Certified through Dec 31, 2026 | 1 package
|
| tirzepatide | 54568-341 | Injection, Solution15 mg/0.6 mL | Unfinished, for further processingDRUG FOR FURTHER PROCESSING | Since Feb 6, 2024Certified through Dec 31, 2027 | 4 packages
|
| tirzepatide | 54568-342 | Injection, Solution12.5 mg/0.6 mL | Unfinished, for further processingDRUG FOR FURTHER PROCESSING | Since Feb 6, 2024Certified through Dec 31, 2027 | 4 packages
|
| tirzepatide | 54568-343 | Injection, Solution10 mg/0.6 mL | Unfinished, for further processingDRUG FOR FURTHER PROCESSING | Since Feb 6, 2024Certified through Dec 31, 2027 | 4 packages
|
| tirzepatide | 54568-344 | Injection, Solution7.5 mg/0.6 mL | Unfinished, for further processingDRUG FOR FURTHER PROCESSING | Since Feb 6, 2024Certified through Dec 31, 2027 | 4 packages
|
| tirzepatide | 54568-345 | Injection, Solution5 mg/0.6 mL | Unfinished, for further processingDRUG FOR FURTHER PROCESSING | Since Feb 6, 2024Certified through Dec 31, 2027 | 4 packages
|
| tirzepatide | 54568-346 | Injection, Solution2.5 mg/0.6 mL | Unfinished, for further processingDRUG FOR FURTHER PROCESSING | Since Feb 6, 2024Certified through Dec 31, 2027 | 4 packages
|
| tirzepatide | 54568-460 | Injection, Solution12.5 mg/0.5 mL | Unfinished, for further processingDRUG FOR FURTHER PROCESSING | Since Aug 12, 2022Certified through Dec 31, 2026 | 1 package
|
| tirzepatide | 54568-471 | Injection, Solution10 mg/0.5 mL | Unfinished, for further processingDRUG FOR FURTHER PROCESSING | Since Aug 12, 2022Certified through Dec 31, 2026 | 1 package
|
| tirzepatide | 54568-837 | Injection, Solution7.5 mg/0.5 mL | Unfinished, for further processingDRUG FOR FURTHER PROCESSING | Since Jul 13, 2023Certified through Dec 31, 2026 | 1 package
|
| Dulaglutide | 54568-001 | Injection, Solution1.5 mg/0.5 mL | Unfinished, for further processingDRUG FOR FURTHER PROCESSING | Since Jan 21, 2021Certified through Dec 31, 2026 | 3 packages
|
| Dulaglutide | 54568-003 | Injection, Solution3 mg/0.5 mL | Unfinished, for further processingDRUG FOR FURTHER PROCESSING | Since Aug 4, 2022Certified through Dec 31, 2026 | 2 packages
|
| Dulaglutide | 54568-004 | Injection, Solution4.5 mg/0.5 mL | Unfinished, for further processingDRUG FOR FURTHER PROCESSING | Since Aug 24, 2023Certified through Dec 31, 2026 | 1 package
|
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
- Unfinished, for further processing. Drug made to be processed further by another firm (filled, packed or finished elsewhere), not sold to patients in this form.
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. Tirzepatide is the ingredient in Mounjaro, Zepbound; Dulaglutide is the ingredient in Trulicity.
“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 ↗
“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 tirzepatide and dulaglutide
FDA registers on this site
Sources
- FDA NDC directory via openFDA ↗, updated by FDA .
- 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.