Tirzepatide
ZEPBOUND
ZEPBOUND is an FDA-approved tirzepatide prescription product for defined uses. The ingredient also appears in other product and online-sales contexts that belong to different regulatory records.
The ingredient is a GIP and GLP-1 receptor agonist.
The application number distinguishes ZEPBOUND from other tirzepatide records.
The current label includes defined weight-management and obstructive-sleep-apnea populations.
The current label carries a boxed warning about thyroid C-cell tumors.
Resolve the application before the claim.
- Brand
- ZEPBOUND
- Active ingredient
- Tirzepatide
- US application
- NDA 217806
- Company named in current label
- Lilly USA, LLC
- Dosage form
- Injection
- Route
- Subcutaneous
- Approval record
- ZEPBOUND NDA first approved in 2023
- Label record updated
- April 22, 2026
What this approval covers - and what it does not.
This summary stays intentionally high level. Use the current full prescribing information for complete warnings, contraindications, adverse reactions, and instructions.
The exact approved record
The current US label covers chronic weight management in specified adults and treatment of moderate-to-severe obstructive sleep apnea in adults with obesity. The prescribing information defines the eligible populations and limitations.
Open current label ↗An ingredient match is not product equivalence
This record describes ZEPBOUND under NDA 217806. Mounjaro is a separate tirzepatide product with a separate indication and application, while compounded or unapproved tirzepatide products do not inherit ZEPBOUND's approval or label.
Read the category guide →Tirzepatide across 42 countries.
This record starts with the exact US FDA medicine identity. The global and state maps keep authorization, presentation, prescription route, market status, pharmacy, and seller records separate.
Compare Tirzepatide by country →Compare Tirzepatide by US state →The questions behind the medicine search.
Answers are based on the dated FDA and DailyMed records below. They are educational reporting, not a diagnosis, prescription, or treatment recommendation.
Are tirzepatide, Zepbound, and Mounjaro interchangeable names?
No. Tirzepatide is the active ingredient. ZEPBOUND and Mounjaro are distinct approved products with separate FDA applications and labeled uses. Ingredient-level search results should be resolved to the exact brand, application, presentation, and current label.
What is Zepbound FDA approved for?
The current label covers chronic weight management in specified adults and moderate-to-severe obstructive sleep apnea in adults with obesity. The label contains the full eligibility, warnings, and limitations; this page is an evidence index, not an individual treatment recommendation.
Does the Zepbound approval cover compounded tirzepatide?
No. FDA approval applies to the product reviewed under NDA 217806. Compounded drugs are not FDA approved before marketing, and an ingredient match does not transfer ZEPBOUND's manufacturing review, presentation, or label.
Use the current full prescribing information and a licensed clinician or pharmacist for medicine-specific decisions. Do not substitute a research product, investigational program, or unapproved seller listing for an FDA-approved product.
Open safety and verification resources →