FDA record shows revised Mounjaro package insert dated May 28, 2025

The FDA has posted a revised package insert for Mounjaro, the tirzepatide injection made by Eli Lilly and Co. The change was filed as supplement S-031 to the drug's new drug application, NDA 215866, with an action date of May 28, 2025 ^[1].

The agency classifies S-031 as "Labeling-Package Insert" ^[1]. FDA uses the same category for routine text and formatting updates to a drug's prescribing information. Earlier Mounjaro insert updates carry similar labels: supplements S-2 and S-6 were acted on July 28, 2023, and supplements S-10, S-15 and S-22 on Nov. 1, 2024 ^[1]. The record for S-031 does not describe what changed in the insert, and no summary of the change appears in the posting. The revised label itself is posted as a PDF ^[1].

FDA files different kinds of changes under different headings, and that distinction is visible in this application's history. The same record separately lists supplements classified as "Efficacy-New Indication" and "Efficacy-New Dosing Regimen," along with "Manufacturing (CMC)-Packaging" ^[1]. S-031 appears only under the labeling category, not under any of those.

Mounjaro was first approved on May 13, 2022, under a priority review, classified as a Type 1 new molecular entity ^[1]. FDA's current product table for NDA 215866 lists 24 entries: single-dose presentations at 2.5, 5, 7.5, 10, 12.5 and 15 mg per 0.5 mL, autoinjector versions at the same six strengths, and multi-dose KwikPen or vial formats at 10, 20, 30, 40, 50 and 60 mg per 2.4 mL ^[1]. All are subcutaneous solutions, all are prescription products, and FDA lists no therapeutic equivalence code for them. Mounjaro is listed as the reference drug for the application ^[1].

Why it matters for patients

The package insert is the FDA-approved prescribing information that clinicians and pharmacists consult, and the medication guide is the version written for patients. A revised insert means the official document has changed, but this record does not say whether the change touches dosing, warnings, drug interactions or only wording, and it does not say which version of the document is affected by which prior update ^[1].

Nothing in the record indicates a change to the product itself. The strengths and device types FDA currently lists for NDA 215866 are all prescription-only formulations, and no generic equivalent is listed ^[1]. Mounjaro contains tirzepatide, a different molecule from semaglutide, the active ingredient in Ozempic, Wegovy and Rybelsus. The two are not interchangeable, and nothing in this record changes that ^[1].

FDA's supplement categories do not by themselves show whether an approved use or a dosing schedule changed, because the agency tracks new indications and new dosing regimens as separate supplement types on this same application ^[1].

What happens next

FDA's approval history for NDA 215866 lists later submissions on the same application, each with a posted action date and label: S-34 (Sept. 25, 2025, labeling), S-39 (Dec. 19, 2025, new patient population), S-41 (Jan. 7, 2026, manufacturing-packaging), S-9 (Jan. 20, 2026, labeling including a medication guide), and S-44 and S-45, both dated Aug. 27, 2026, classified as a new indication and a new dosing regimen ^[1]. The listing does not describe what any of those submissions contain, and it does not say when any future insert changes tied to them would take effect ^[1].