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HealthRX.com · Printable question sheet

Zepbound presentation and label record

Record which Zepbound presentation and dose you use, check it against the dates FDA approved each one, and note what differs if a prescription is filled in Canada, Japan or the EU. Questions for your prescriber or pharmacist are included.

Companion to “Zepbound Global Regulatory Status: FDA Approval, Label Details, and Safety Profile” · healthrx.com/regulatory-zepbound/global-regulatory · Facts checked 2026-10-19

What you use

Presentationsingle-dose pen, single-dose vial, multiple-dose vial or KwikPen
Dose per injection
Use it is prescribed forweight management, obstructive sleep apnea, or both
Country and pharmacy where it is filled

US presentations and uses, by FDA approval date

  • November 8, 2023: Zepbound approved for chronic weight management in adults.[1]
  • March 28, 2024: single-dose vial added.[2]
  • December 20, 2024: moderate to severe obstructive sleep apnea in adults with obesity added as an indication.[3]
  • February 7, 2025: a four-pack of single-dose vials added.[4]
  • January 7, 2026: a multiple-dose single-patient vial added.[5]
  • January 20, 2026: six KwikPen strengths added, each pen holding 4 weekly doses.[6]

If the prescription is filled outside the US

  • Canada: Zepbound KwikPen is for adults only, with a maximum of 15 mg once weekly.[7]
  • Japan: the usual dose rises in 2.5 mg steps every 4 weeks to 10 mg once weekly, with up to 15 mg allowed.[8]
  • European Union: tirzepatide for weight management is sold under the Mounjaro name.[9]

For your prescriber or pharmacist

  1. If I change from pens to vials or the KwikPen, what changes in how I measure or inject each dose?
  2. Is my prescription written for weight management, sleep apnea, or both?
  3. If I fill a prescription outside the US, which product name and dose will I be given there?
  4. Has any label change since I started affected my warnings or monitoring?

Fills

DatePresentationStrengthPharmacy and countryNotes
Sources for the facts on this sheet
  1. U.S. Food and Drug Administration. NDA 217806 approval letter for Zepbound (tirzepatide) injection. Accessed 2026-10-19. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217806Orig1s000ltr.pdf
  2. U.S. Food and Drug Administration. NDA 217806/S-003 corrected supplement approval letter for Zepbound (tirzepatide) injection. Accessed 2026-10-19. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s003Corrected_ltr.pdf
  3. U.S. Food and Drug Administration. NDA 217806/S-013 supplement approval letter for Zepbound (tirzepatide) (obstructive sleep apnea). Accessed 2026-10-19. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217806Orig1s013ltr.pdf
  4. U.S. Food and Drug Administration. NDA 217806/S-020 supplement approval letter for Zepbound (tirzepatide) injection. Accessed 2026-10-19. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/217806Orig1s020ltr.pdf
  5. U.S. Food and Drug Administration. NDA 217806/S-037 supplement approval letter for Zepbound (tirzepatide) injection. Accessed 2026-10-19. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217806Orig1s037ltr.pdf
  6. U.S. Food and Drug Administration. NDA 217806/S-002 supplement approval letter for Zepbound KwikPen (tirzepatide) injection. Accessed 2026-10-19. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217806Orig1s002ltr.pdf
  7. Health Canada, Drug Product Database. Zepbound (tirzepatide injection) KwikPen product monograph, Health Canada Drug Product Database. Accessed 2026-10-19. https://pdf.hres.ca/dpd_pm/00084150.PDF
  8. Pharmaceuticals and Medical Devices Agency; Ministry of Health, Labour and Welfare (Japan). Report on the Deliberation Results and Review Report: Zepbound Subcutaneous Injection Ateos (tirzepatide), English translation. Accessed 2026-10-19. https://www.pmda.go.jp/files/000278664.pdf
  9. European Medicines Agency. Mounjaro: EPAR (European public assessment report) page. Accessed 2026-10-19. https://www.ema.europa.eu/en/medicines/human/EPAR/mounjaro

This sheet records information for a conversation with your prescriber or pharmacist. It does not replace their instructions or the medication's prescribing information.