FDA record shows February 2025 labeling update for Zepbound

The FDA's approval record for Zepbound (tirzepatide) shows a labeling update with an action date of Feb. 7, 2025, covering the drug's package insert and its container and carton labels ^[1]. The action is listed as supplement SUPPL-20 to New Drug Application (NDA) 217806, which is held by Eli Lilly and Co. ^[1].

Zepbound was first approved on Nov. 8, 2023, under priority review ^[1]. The February 2025 supplement falls under the categories "Labeling-Package Insert" and "Labeling-Container/Carton Labels" ^[1]. Those categories describe which documents were revised: the prescribing information that comes with the drug, and the printed labeling on the carton or container. The FDA listing links to a label document dated 2025 but does not summarize the edits or say whether they involved dosing, warnings, storage instructions or only formatting ^[1]. The specific changes have not been disclosed in that record.

NDA 217806 covers a wide range of Zepbound presentations, all prescription subcutaneous solutions. The listing includes single-dose pens at 2.5, 5, 7.5, 10, 12.5 and 15 mg per 0.5 mL; single-dose vials at 10, 20, 30, 40, 50 and 60 mg per 2.4 mL; an autoinjector in the same six single-dose strengths; and Zepbound KwikPen multi-dose pens at 10, 20, 30, 40, 50 and 60 mg per 2.4 mL ^[1]. Zepbound is listed as the reference listed drug for the application, with no therapeutic equivalence code assigned ^[1].

The FDA record shows that the Feb. 7, 2025 supplement was one of several labeling actions on this application. Earlier entries include March 28, 2024 (SUPPL-3), Oct. 18, 2024 (SUPPL-5, 6, 11, 15 and 19) and Dec. 20, 2024 (SUPPL-13, an efficacy supplement for a new indication) ^[1]. The same record also lists later labeling supplements, with action dates of Sept. 25, 2025 for the medication guide and package insert; Jan. 20, 2026 for container and carton labels, package insert and medication guide; Feb. 25, 2026 for the package insert; and Aug. 26, 2026 for an efficacy-labeling change with clinical data ^[1]. The record does not describe the contents of those actions either.

Why it matters for patients

The package insert is the prescribing information that clinicians, pharmacists and patients rely on, and the medication guide is the FDA-approved leaflet written for patients. Carton labeling is what is printed on the box a patient receives from the pharmacy. A labeling supplement means those documents were revised as of the action date ^[1].

Because the FDA listing does not describe the edits made in SUPPL-20, it is not known from this record whether the February 2025 change affected how the drug is described for use, which side effects or warnings are listed, how it should be stored, or only administrative or formatting details ^[1]. Patients filling a Zepbound prescription may see different packaging than before, since carton labeling was part of the supplement ^[1]. Whether the change affected insurance coverage, pharmacy substitution or dispensing has not been reported.

Labeling changes for tirzepatide apply to Zepbound specifically; NDA 217806 covers Zepbound, and the same active ingredient is also sold under a different brand name for a different set of uses, which is a separate application.

What happens next

No upcoming action on this supplement is listed, because the Feb. 7, 2025 action is complete ^[1]. The FDA record does not state whether further labeling revisions are pending for the package insert, carton labels or medication guide.

Label versions and approval letters for each supplement are posted publicly on the FDA's Drugs@FDA page for NDA 217806, so the documents themselves can be compared directly ^[1]. No statement from Eli Lilly and Co. about the February 2025 revision appears in the FDA record ^[1].